DHS 281.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982176684), received between Nov 12, 2019 and Nov 4, 2025 — classified as 2 injuries.

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

• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 23468104 ↗
• InjuryNov 12, 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 A HARDWARE REMOVAL DUE TO INFECTION AND A MALUNION. THE SURGEON STATED THAT THERE WAS NO COMPLAINT ABOUT THE DEVICE AND THAT THE OPERATING SURGEON IN (B)(6) IN 2018 MAL REDUCED THE FRACTURE WHICH LED TO RE-OPERATION. THE PROCEDURE WAS THEN COMPLETED. THE PATIENT WILL RETURN IN 6 WEEKS FOR THE INSERTION OF AN UNKNOWN BLADE AND AN UNKNOWN PLATE AFTER OSTEOTOMY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS 3 OF 3 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9312002 ↗