Volar Bearing Plates VBEAR-3-7SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842188125027), received between May 23, 2025 and Sep 29, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Fell” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 28, 2023Class IIOpen, Classified

   Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

   Z-0932-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Unintended Movement; Device Fell

  Distributor reported on (b)(6) 2026 that a surgeon was placing a competitor's dorsal plate due to previous TriMed wrist construct failing, this construct included VBEAR-3-7S with 2.4TPEG and 3.2mm cortical and locking screws. The original TriMed wrist construct was implanted on (b)(6) 2026 and removed on (b)(6) 2026. The surgeon was concerned how the distal screws migrated proximally and one of the bearers came out of the plate. The orthopaedic surgeons advised the patient didn't fall prior to the plate removal and no other incidents were reported by the surgeons. It was reported that the patient was was a 67 yr female, it is unknown if the patient has poor bone quality and it is believed she would have comorbidities however unaware of what they are. The revision surgery was successful with no delay in surgery and no additional reported adverse event.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934716 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SALES REP REPORTED ON 10JUN2025 THAT A SURGEON HAD TWO WS3 VOLAR BEARING PLATE FAILURES WHERE HE INDICATED HE THOUGHT THE BEARING WASN'T LOCKING INTO THE PLATE PROPERLY. A SALES REP PROVIDED ADDITIONAL INFORMATION ON 25JUN2025 WITH X-RAYS FOR BOTH CASES AND THE DEVICES WERE IDENTIFIED AS THE VBEAR-3-7S AND VBEAR-5-7S. THE SURGEON REPORTED THAT THERE WERE NO POST-OP INJURIES AND NO ASSOCIATED CO-MORBIDITIES. REVISION SURGERY WAS AFTER 3 MONTHS FOR THE 1ST PATIENT, VBEAR-3-7S (EXACT IMPLANT DATE AND REMOVAL DATE UNK) AND 4 MONTHS AFTER FOR THE SECOND PATIENT VBEAR-5-7S (EXACT IMPLANT DATE AND REMOVAL DATE UNK). IT WAS OBSERVED THROUGH X-RAY PHOTOS PROVIDED THAT THE PROXIMAL ROW OF THE PLATE DID NOT HAVE ANY SCREWS IMPLANTED. THE SURGEON STATED THAT DURING THE INITIAL SURGERY THE BEARINGS WERE LOCKED AT THE END OF BOTH CASES. FINALLY, IT WAS REPORTED THAT THE 1ST PATIENT HAD ADDITIONAL SURGERY TO REMOVE THE PLATE AND THE 2ND PATIENT RUPTURED HER FPL TENDON WHICH WILL REQUIRE RECONSTRUCTION OF THE TENDON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438757 ↗
• MalfunctionMay 23, 2025Unintended Movement; Device Fell; Unintended Movement; Device Fell

  A SALES REP REPORTED ON 29APR2025 THAT WHILE REVIEWING POST-OP X-RAYS, THE SURGEON NOTICED THE BEARINGS ON THE VBEAR-3-7S HAD COLLAPSED. IT WAS REPORTED THAT THE INTRA-OP X-RAYS TAKEN ON (B)(6) 2025 LOOKED GOOD FOR THE PLATE AND REVISION SURGERY OCCURRED ON (B)(6) 2025. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED BY A FELLOW WITH AN EXPERIENCED REP IN THE ROOM, THE PROXIMAL SCREWS WERE NOT IMPLANTED SINCE THE FELLOW FELT THE DISTAL ROW FIXATION WAS ADEQUATE AND BELIEVED ALL BEARINGS WERE LOCKED. IT WAS STATED THAT THE PATIENT WAS COMPLIANT WITH POST-OP INSTRUCTIONS. INTRA-OP AND POST-OP X-RAYS WERE PROVIDED BUT PRE-OP X-RAYS COULD NOT BE OBTAINED AND THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079951 ↗