Volar Bearing Plates VBEAR-11-7SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188125119), received between May 23, 2025 and May 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Fell” (1 report).

1 other recall cover devices cleared under the same FDA submission (K222637); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Unintended Movement; Device Fell; Unintended Movement; Device Fell

  A SALES REP REPORTED ON 29APR2025 THAT WHILE REVIEWING THE POST-OP X-RAYS ON (B)(6) 2025 THE SURGEON NOTICED THE ULNA CORNER BEARING HAD COLLAPSED ON THE VBEAR-11-7S. IT WAS REPORTED THAT THE INTRA-OP X-RAYS TAKEN ON (B)(6) 2024 LOOK REASONABLE FOR THE 11-HOLE BEARING PLATE AND REVISION SURGERY HAS NOT YET BEEN CONFIRMED. IT WAS REPORTED THAT THE 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 REMAINS IMPLANTED UNTIL THE REVISION SURGERY IS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079957 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222637. One submission often covers many models, so check the product and lot details in each record.

• Z-0932-2024 · Nov 28, 2023 · Open, Classified
  Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3