NA 204.844Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982146403), received between Jun 2, 2020 and Jan 31, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT (B)(6) 2022, THEY HAD A BROKEN SCREW. THE HEAD WAS REMOVED(HEAD RETRIEVED) AND SHAFT RETAINED IN PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS UNKNOWN. THIS COMPLAIN INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 44MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273548 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY TO REMOVE HARDWARE DUE TO PAIN. THE PATIENT HAD SOME PAINFUL HARDWARE AFTER BONE HEALING AND THUS REQUESTED IT BE REMOVED IF HEALING WAS COMPLETED. THE HEALING WAS COMPLETED, SO NO LONGER NEEDED HARDWARE WAS REMOVED. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 44MM. THIS REPORT IS 2 OF 9 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11156025 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION AND HARDWARE REMOVAL. THE REVISION SURGERY WAS DUE TO INFECTION AND NON-UNION OF 2 CORTEX SCREWS, 1 TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND, 4 TITANIUM LOCKING SCREW AND 1 TITANIUM END CAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW SELF-TAPPING 40MM (PART NUMBER 204.84, LOT UNKNOWN, QUANTITY 1), 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE (PART NUMBER 04.034.449S, LOT 22P4336, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS (PART NUMBER 04.005.530, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS (PART NUMBER 04.005.528, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS (PART NUMBER 04.005.526, LOT UNKNOWN, QUANTITY 1), TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX (PART NUMBER 04.004.000, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 3.5MM CORTEX SCREW SELF-TAPPING 44MM. THIS IS REPORT 2 OF 8 FOR (B

  Patient problems: Bone Fracture(s); No Code Available; Unspecified Infection

  MAUDE report 10108363 ↗