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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842188124938), received between May 23, 2025 and Sep 9, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Fell” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Insufficient Device Problem Information

  Sales Rep reported on (b)(6) 2026 that a when a surgeon was implanting a VBEAL-3-7, a TPEG2.4 screw passed through the plate. The surgeon had to remove the already implanted screws and plate to switch to a new VBEAL-3-7S to complete the surgery which took approx. 30 minutes. The second plate was implanted successfully with no further issues. The rep was not present during the case but after they spoke to the R4, he believed the bearing was disrupted when they drilled using the single sided tissue protector. After TriMed Product Management spoked with the rep, the rep is unsure if the bearing popped out and did not know which screw hole was affected. Another sales rep stated on (b)(6) 2026 that the surgeon did not use the term that the bearing popped out but when they advanced the screw the screw basically broke through the bearing using the TPEG 2.4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696722 ↗
• InjurySep 8, 2026Unintended Movement; Device Fell

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

  MAUDE report 50677715 ↗
• MalfunctionAug 29, 2025Unintended Movement; Device Fell; Unintended Movement; Device Fell

  SALES REP REPORTED ON 03AUG2025 THAT THE DISTAL SCREWS COLLAPSED IN A VBEAL-3-7S. ORIGINAL IMPLANT DATE IS UNKNOWN. ADDITIONAL INFORMATION WAS PROVIDED ON 12AUG2025 WHERE THE REP STATED NO DEVICES BROKE, THIS WAS NOT A REMOVAL SURGERY, THE DEVICE REMAINS IMPLANTED AND THERE WAS NO REPORTED ADVERSE EVENT. A SECOND FOLLOW-UP ON (B)(6) 2025 INDICATED THAT THERE IS NO REVISION SURGERY PLANNED, THERE IS NO PATIENT DISCOMFORT AND THE SURGEON BELIEVES THE PATIENT WILL HEAL PROPERLY WHILE LEAVING THE PLATE INSITU. TRIMED FOLLOWED UP AGAIN ON (B)(6) 2025 TO GATHER ADDITIONAL X-RAYS AND MORE INSIGHT ON HOW THIS ISSUE WAS DISCOVERED BY THE SURGEON. AN X-RAY WAS PROVIDED ON (B)(6) 2025, WHICH SHOWS THE PLATE IS PARTIALLY FIXED TO THE BONE WITH NO DETAILS ON THE DATE AND TIME OF THE X-RAY. PLATE STILL REMAINS IMPLANTED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925953 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SALES REP REPORTED ON 09JUL2025 THAT WHEN THE SURGEON WAS REMOVING A VBEAL-3-7S, THE DISTAL SCREWS IN THE PLATE WOULD NOT DISENGAGE FROM THE BEARINGS. IT WAS REPORTED THAT THIS CAUSED A SIGNIFICANT DELAY IN THE CASE (OVER 20 MINS). THE SURGEON WAS ABLE TO EVENTUALLY REMOVE THE PLATE EVEN THOUGH ALL SCREWS WERE NOT ABLE TO DISENGAGE. ADDITIONAL INFORMATION WAS RECEIVED ON 22JUL2025 WHICH THE REP STATED THE SURGEON SUSPECTS THE PATIENT DID FALL POST-OP. HE DIRECTED THIS INQUIRY TO THE PATIENT, HOWEVER, THE PATIENT DENIED THIS OCCURRED. THE SURGEON ALSO NOTICED THE PATIENT WAS NO LONGER WEARING HIS SPLINT WHEN HE ARRIVED FOR A POST-OP VISIT WHICH THE SURGEON THOUGHT WAS SUSPICIOUS. THE SURGEON REVEALED HE GAVE THE PATIENT SPECIFIC INSTRUCTIONS TO NOT REMOVE THE SPLINT. FINALLY, IT WAS CONFIRMED THAT THERE WAS CAUSE FOR REMOVAL OF THE PLATE. X- RAYS AND CLINIC NOTES FROM PHYSICAL EXAM ON (B)(6) 2025 IDENTIFIED LOSS OF FIXATION AS WELL AS PROMINENCE ON THE DISTAL END OF THE VOLAR BEARING PLATE. THE FRACTURE HAD HEALED IN A POOR POSITION BECAUSE OF HARDWARE FAILURE WHICH CAUSED PATIENT DISCOMFORT. ALSO, THE SURGEON REPORTED DURING REMOVAL THE DISTAL ROW OF SCREWS APPEARED MISALIGNED FR

  Patient problems: Malunion of Bone

  MAUDE report 22688403 ↗
• MalfunctionMay 23, 2025Unintended Movement; Device Fell; Unintended Movement; Device Fell

  A SALES REP REPORTED ON 29APR2025, THAT WHILE REVIEWING POST-OP X-RAYS ON (B)(6) 2025 THE SURGEON NOTICED THE BEARINGS ON THE VBEAL-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 DATE HAS NOT BEEN CONFIRMED. 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 REMAINS IMPLANTED UNTIL THE REVISION SURGERY IS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079965 ↗
• MalfunctionMay 23, 2025Unintended Movement; Device Fell; Unintended Movement; Device Fell

  A SALES REP REPORTED ON 29APR2025 THAT WHILE REVIEWING POST-OP X-RAYS ON (B)(6) 2025 THE SURGEON NOTICED THE BEARINGS ON THE VBEAL-3-7S HAD COLLAPSED. IT WAS REPORTED THAT THE INTRA-OP X-RAYS TAKEN ON (B)(6) 2025 LOOK GOOD FOR THE PLATE AND REVISION SURGERY WAS PERFORMED 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 HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079961 ↗