VA-LCP 04.117.502SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982106339), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K120070); 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.

• MalfunctionFeb 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SPECTROSCOPIC FRACTURE SURGERY FOR DISTAL COMMISSURAL FRACTURE OF THE HUMERUS WITH THE PRODUCTS IN QUESTION. SCREW INSERTION WAS PERFORMED AFTER DRILLING WITH A FUNNEL-SHAPED SLEEVE IN A VA 2.7 HOLE, BUT DID NOT LOCK. THAT SCREW IN QUESTION WAS REMOVED AND ANOTHER HOLE WAS USED TO FIX THE PLATE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SCREW THAT REMOVED HAD SCRATCHES ON IT. INSERTING THE REMOVED SCREW INTO THE PLATE SAMPLE LOCKED IT WITHOUT ANY PROBLEM. IT IS INFERRED THAT THE LOCKING MECHANISM OF THE HOLE FAILED DUE TO THE GRIPPING WHEN THE FUNNEL-SHAPED SLEEVE WAS INSTALLED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/2H/LT/82MM-MED-STER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361998 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes