Plate, Cranioplasty, Preformed, Non-Alterable
FDA adverse event reports and recall history for plate, cranioplasty, preformed, non-alterable (product code GXN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 822
- Deaths
- 2
- Injuries
- 554
- Malfunctions
- 230
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.
Recent recalls
- 2015-09-23TerminatedLabeling False and Misleading
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.
- TerminatedProcess control
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- TerminatedProcess control
Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- TerminatedProcess control
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- TerminatedProcess control
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- TerminatedProcess control
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- TerminatedProcess control
Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
- TerminatedDevice Design
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
- TerminatedDevice Design
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
- TerminatedDevice Design
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
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