VA-LCP 04.117.901SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982107077), received between Jul 28, 2023 and Jul 28, 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.

• MalfunctionJul 28, 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 AN ORIF SURGERY FOR DISTAL HUMERUS FRACTURE. THE AFFECTED AREA WAS FIXED IN THE ORDER OF THE MEDIAL PLATE, THEN THE LATERAL PLATE. INITIALLY, THE SCREW WAS INSERTED AT A FIXED ANGLE, BUT WHEN IT WAS CHECKED WITH AN IMAGE INTENSIFIER, IT WAS FOUND THAT THE TIP OF THE SCREW PENETRATED FORWARD. THE SCREW WAS REMOVED AND REINSERTED SEVERAL TIMES, BUT THE ANGLE DID NOT CHANGE SO THE SURGEON REDRILLED WITH A VARIABLE ANGLE AND INSERTED THE SCREW. NEAR THE END OF THE LATERAL PLATE FIXATION, THE SURGEON SAID THAT THE 2ND SCREW FROM THE DISTAL SIDE COULD NOT BE LOCKED AND WAS COMING OUT. THE SCREW CAME OUT, SO NO SCREW WAS INSERTED IN THAT SCREW HOLE. ONLY ONE SCREW COULD BE INSERTED DISTALLY, SO AN ADDITIONAL SCREW WAS INSERTED FROM THE DISTAL LATERAL DIRECTION TO THE PROXIMAL LATERAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM/3.5MM TI VA-LCP LAT DSTL HUM PL 1H/LT/69MM SHRT-STER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415920 ↗

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