NA 212.209Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982152169), received between May 9, 2018 and Sep 15, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length, but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773359 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that there was frequent issues getting 2.4mm locking screws to engage near cortex. Customer did not specify any particular screw length, but thinks it happens with all lengths that customer uses.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773345 ↗
• 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 30. THIS IS REPORT 3 OF 7 FOR (B)(4).

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

  MAUDE report 12657411 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643848 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643329 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF HARDWARE ON (B)(6) 2018 DUE TO INFECTION CAUSED BY THE FEMUR IMPLANTS AND PAIN CAUSED BY THE TIBIAL IMPLANTS. IMPLANTS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. DEVICES REMOVED ARE ONE (1) TITANIUM CANNULATED TIBIAL NAIL, ONE (1) TITANIUM END CAP, TWO (2) TITANIUM LOCKING SCREW, ONE (1) LOCKING COMPRESSION (LCP) CURVED CONDYLAR PLATE, ONE (1) PERIPROSTHETIC LOCKING SCREW, ONE (1) LOCKING SCREW, EIGHT (8) CORTEX SCREWS, AND TWO (2) CANNULATED SCREW PARTIALLY THREADED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 17 DEVICES. COMPLAINT (B)(4) CAPTURES 10 DEVICES AND COMPLAINT (B)(4) CAPTURES REMAINING 7 DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 30MM. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7680036 ↗
• 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 30MM. THIS IS REPORT 7 OF 10 FOR (B)(4). THE OTHER SCREW IS BEING CAPTURED ON RELATED (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7497955 ↗