NA 245.17Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982169754), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO FOREARM PAIN. THE PATIENT WAS IMPLANTED WITH ONE (1) RECONSTRUCTION PLATE, ONE (1) UNKNOWN STRYKER VOLAR DISTAL RADIUS PLATE, AND UNKNOWN SCREWS ON AN UNKNOWN DATE. THE FRACTURE WAS HEALED AND THE SYNTHES HARDWARE CAME OUT WITHOUT ISSUES. THEN THE SURGEON INDICATED THAT THERE WAS NO ALLEGATION AGAINST THE PLATES, HE REMOVED BECAUSE THE PATIENT WAS EXPERIENCING FOREARM PAIN. HE INDICATED THAT HE DID NOT BELIEVE IT WAS DUE TO HIS HARDWARE. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN STRYKER VOLAR DISTAL RADIUS PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 MM RECONSTRUCTION PLATE 7 HOLES/82 MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9405788 ↗