NA 202.836Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982144843), received between Dec 22, 2018 and Aug 23, 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. 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.

• InjuryAug 23, 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 FOR A REMOVAL SURGERY. DURING THE SURGERY, ALL DEVICES WERE INTACT, NO ITEMS WERE BROKEN, AND WERE REMOVED SUCCESSFULLY AND WITHOUT DIFFICULTY. ORIGINALLY, THE PATIENT UNDERWENT FOR REMOVAL HARDWARE OF A LEFT TIBIAL SHAFT FRACTURE FOR INFECTION ON (B)(6) 2020. THE CURRENT REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT WAS FIN POSTOPERATIVELY. THIS COMPLAINT INVOLVES (13) DEVICES. THIS REPORT IS FOR (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM. THIS REPORT IS 11 OF 13 FOR (B)(4).

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

  MAUDE report 12356635 ↗
• InjuryDec 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON (B)(6) 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS PERFO

  Patient problems: Unspecified Infection

  MAUDE report 8193034 ↗