VA-LCP 04.112.047SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982102812), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.

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

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.

• MalfunctionJul 30, 2021Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF SHAFT OF CLAVICLE WITH THE PLATE. AFTER REDUCTION, THE PLATE WAS PLACED, BUT THE SURGEON SAID THAT THE PLATE DID NOT FIT WELL ALONG THE BONE. THE SURGEON TRIED TO BEND THE PLATE TO BE FIT ALONG THE BONE, BUT HE GAVE UP BENDING BECAUSE A BENDER WAS NOT ARRANGED. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. IN THE POSTOPERATIVE PHOTOGRAPHS, THE REDUCTION POSITION WAS NOT GOOD, AND IT SEEMED THAT THE PLATE DID NOT FIT ALONG THE BONE WELL. THIS REPORT INVOLVES ONE (1) 2.7MM/3.5MM TI VA-LCP LAT ANT CLAVICLE PL/10H/101MM-STER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252578 ↗