PYRENEES® Cervical Plate System 208-43F60Recalls & reported problems
VB Spine LLC · Constrained Plate, 3 Level Size 60 mm · Class 2 · Implant
All models of PYRENEES Cervical Plate System (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857031173), received between Sep 12, 2016 and Jan 17, 2020 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture1
Patient problems
- Injury1
- No Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2020Fracture; Fracture
LEGAL CASE REPORTED A PATIENT UNDERWENT SURGERY FOR AN ANTERIOR C5-6, C6-7 AND C7-T1 DISCECTOMIES AND FUSION WITH INTERBODY CAGE, ALLOGRAFT AND PLATE. THE SURGERY WAS COMPLETED USING STRYKER'S PYRENEES CONSTRAINED CERVICAL PLATE AND SCREWS. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE BROKEN PYRENEES CONSTRAINED CERVICAL PLATE AND THE BROKEN SCREW ON THE RIGHT AT C5. IT IS ALLEGED THAT THE CERVICAL PLATE WAS TAKEN OUT IN TWO PIECES AND THE RIGHT C5 SCREW HAD BACKED OUT ABOUT 4 THREADS AND WAS LOOSE. APPROXIMATELY A THIRD OF THE SCREW WAS REMOVED AND THE REMAINING PORTION WAS LEFT IN THE BONE. THIS REPORT REPRESENTS THE CERVICAL PLATE.
Patient problems: Injury
MAUDE report 9603610 ↗MalfunctionMar 30, 2017Break; Break
ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED APPROXIMATELY 2 YEARS POST-OP WITH A FRACTURED PLATE. THERE ARE NO PLANS TO REVISE AT THIS TIME.
Patient problems: Pain
MAUDE report 6446445 ↗InjurySep 12, 2016Break; Break
ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A THREE LEVEL PLATE FRACTURED. THERE ARE NO PLANS TO REVISE. THE PATIENT REPORTEDLY HAD A FRACTURED PLATE APPROXIMATELY 4-6 MONTHS POST-OP.
Patient problems: No Information
MAUDE report 5943723 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- 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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