EBI, LLC.
FDA adverse event reports naming EBI, LLC. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: EBI, LLC..
- Total reports
- 1,661
- Deaths
- 2
- Injuries
- 1,461
- Malfunctions
- 195
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Stimulator, Bone Growth, Non-InvasiveLOF1,221
- Orthosis, Spinal Pedicle FixationMNI68
- ScrewdriverHXX63
- Thoracolumbosacral Pedicle Screw SystemNKB56
- Appliance, Fixation, Spinal InterlaminalKWP47
- Stimulator, Invasive Bone GrowthLOE46
- Intervertebral Fusion Device With Bone Graft, LumbarMAX44
- Electrode, CutaneousGXY38
- Appliance, Fixation, Spinal Intervertebral BodyKWQ25
- Orthosis, Spondylolisthesis Spinal FixationMNH13
Recent recalls
- 2024-04-23Open, ClassifiedDevice Design
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-04-23Open, ClassifiedDevice Design
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-04-23Open, ClassifiedDevice Design
20" Lead Wires, Replacement Part Number: 1067724-2
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-04-23Open, ClassifiedDevice Design
48" Lead Wires, Replacement Part Number: 1067724-4
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2015-01-05TerminatedDevice Design
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
- 2014-12-24TerminatedDevice Design
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
- 2014-06-17TerminatedNonconforming Material/Component
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
- 2013-11-27TerminatedNonconforming Material/Component
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
- 2013-11-19TerminatedDevice Design
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
- 2013-09-27TerminatedProcess control
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Monitor EBI, LLC. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.