Depuy Spine, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2007–2022. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Prosthesis, Intervertebral DiscMJO474
• Appliance, Fixation, Spinal Intervertebral BodyKWQ232
• Orthopedic Manual Surgical InstrumentLXH143
• Appliance, Fixation, Spinal InterlaminalKWP139
• Spinal Vertebral Body Replacement DeviceMQP81
• Orthosis, Spinal Pedicle FixationMNI75
• Orthosis, Spondylolisthesis Spinal FixationMNH65
• ScrewdriverHXX63
• Thoracolumbosacral Pedicle Screw SystemNKB56
• Implant, Fixation Device, SpinalJDN45

Recent recalls

• 2019-04-27TerminatedUnder Investigation by firm

  Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)

  A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

• 2019-04-27TerminatedUnder Investigation by firm

  Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)

  A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

• 2015-12-21TerminatedDevice Design

  Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

  Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length

• 2015-05-26TerminatedProcess design

  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

  Device does not mate as intended.

• 2013-10-23TerminatedUnder Investigation by firm

  PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

  Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

• 2013-10-23TerminatedUnder Investigation by firm

  PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

  Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

• 2013-10-23TerminatedUnder Investigation by firm

  PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

  Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

• 2013-10-23TerminatedUnder Investigation by firm

  PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

  Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

• 2013-10-23TerminatedUnder Investigation by firm

  PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

  Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

• 2013-09-03TerminatedProcess control

  CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

  During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.