CAYMAN® Plate System 1201-16028Recalls & reported problems
VB Spine LLC · Screw Size Ø6.0x28 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857018617), received between Apr 5, 2017 and Jul 18, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Migration2
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2019Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT DURING A ROUTINE POST-OP FOLLOW-UP X-RAY, THE SURGEON NOTED A CAYMAN SCREW BACKED OUT. THE SCREW REMAINS IMPLANTED IN THE PATIENT. REVISION SURGERY IS NOT PLANNED AT THIS TIME. THIS RECORD REPRESENTS 2 OF 2 SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803824 ↗MalfunctionJul 18, 2019Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT DURING A ROUTINE POST-OP FOLLOW-UP X-RAY, THE SURGEON NOTED A CAYMAN SCREW BACKED OUT. THE SCREW REMAINS IMPLANTED IN THE PATIENT. REVISION SURGERY IS NOT PLANNED AT THIS TIME. THIS RECORD REPRESENTS 1 OF 2 SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803813 ↗MalfunctionApr 5, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A POSSIBLE SCREW BACK-OUT. THE PATIENT REPORTEDLY HAD POSSIBLE SCREW BACK-OUT APPROXIMATELY 2 MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME. THE PATIENT IS ASYMPTOMATIC.
Patient problems: No Information
MAUDE report 6460500 ↗
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- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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