NA 212.208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982152152), received between May 9, 2018 and Oct 19, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION FIXATION OF HARDWARE. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THE IMPLANTS WERE ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 28. THIS IS REPORT 6 OF 7 FOR (B)(4).

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

  MAUDE report 12657648 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION FIXATION OF HARDWARE. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THE IMPLANTS WERE ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 28. THIS IS REPORT 5 OF 7 FOR (B)(4).

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

  MAUDE report 12657606 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION FIXATION OF HARDWARE. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THE IMPLANTS WERE ORIGINALLY PLACED IN THE PATIENT ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 28. THIS IS REPORT 2 OF 7 FOR (B)(4).

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

  MAUDE report 12657361 ↗
• 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), A COPY IS ATTACHED. 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 28MM. THIS IS REPORT 6 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497921 ↗