Volar Bearing Plates VBEAR-5-7SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842188125034), received between Oct 10, 2024 and Jul 8, 2025 — classified as 2 injuries.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 22438760 ↗
• InjuryOct 10, 2024Device Dislodged or Dislocated; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Device Dislodged or Dislocated; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  SALES REP REPORTED ON 11SEP2024 THAT AFTER AN ORIGINAL CORRECTIVE DISTAL RADIUS OSTEOTOMY PERFORMED ON (B)(6) 2024 THE PATIENT PRESENTED POST OP REQUIRING REVISION SURGERY ON (B)(6) 2024. IT WAS STATED THAT THE OSTEOTOMY PERFORMED AND VBEAR-5-7S WAS IMPLANTED AS PER SURGICAL TECHNIQUE. IT WAS REPORTED THAT UPON REVIEW, IT APPEARS THE DISTAL SCREW FIXATION (SCREWS LOCKED INTO THE BEARING) HAVE MOVED INTO FLEXION. THIS MOVEMENT SUBSEQUENTLY MEANT THE BEARING AND SCREW INTERFACE SHIFTED NOT ALLOWING EASY SCREWDRIVER INTERFACE WITH THE SCREW HEAD. THE SCREWS WERE IMPEDED BY THE PLATE ITSELF MAKING EXTRACTION DIFFICULT. ON EXAMINATION THE SCREWS PRESENTED TIGHT AND LOCKED IN THE BEARING. THIS AFFECTED THE 4 DISTAL SCREWS. THE SURGEON WAS ABLE TO REMOVE SCREWS AND SUPPLEMENT WITH ADDITIONAL FIXATION. HE ELECTED TO KEEP THE EXISTING VOLAR BEARING PLATE INSITU AND INSERT NEW SCREWS IN THE DISTAL ROW. PROSTHESIS CHOICE, FINAL TECHNIQUE AND FIXATION MADE AT SURGEONS' DISCRETION. THE SURGEON REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND DISCOMFORT POST OP WHICH LED TO FURTHER EXAMINATION/IMAGING AND THUS THE REVISION OPERATION. THE SURGEON WAS UNSURE AT THE TIME OF THE REVISION SURGERY IF

  Patient problems: Implant Pain

  MAUDE report 20417758 ↗