NA 02.100.302Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982028723), received between Jun 17, 2021 and Mar 27, 2024 — classified as 6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH DATA FOR Q3 AND Q4 2023. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: "OTHER INFECTION". THIS REPORT IS FOR A 3.5MM SPRING PLATE/2 HOLES. THIS REPORT IS 4 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18989328 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 3.5MM SPRING PLATE/2 HOLES. THIS REPORT IS 12 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017998 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (13) DEVICES. THIS REPORT IS FOR (1) 3.5MM SPRING PLATE/2 HOLES. THIS REPORT IS 9 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017989 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (13) DEVICES. THIS REPORT IS FOR (1) 3.5MM SPRING PLATE/2 HOLES. THIS REPORT IS 11 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017988 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 3.5MM SPRING PLATE/2 HOLES. THIS REPORT IS 10 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017985 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 3.5MM SPRING PLATE/2 HOLES. THIS REPORT IS 6 OF 13 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12017960 ↗