NA 212.207Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982152145), received between May 9, 2018 and Jun 15, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DUE TO INFECTION THE PATIENT UNDERWENT FOR A REVISION SURGERY TO REMOVE DEFECTIVE FRACTURED 4.5 MM PROXIMAL TIBIAL PLATE AND OTHER ASSOCIATED SCREWS. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 26. THIS REPORT IS 7 OF 7 FOR PC (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

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

  MAUDE report 12001925 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT CAPTURES ONE 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 26MM. THIS IS REPORT 5 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497919 ↗