NA 204.840Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982146380), received between Mar 1, 2019 and Apr 12, 2022 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 10 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090328 ↗
• InjuryFeb 3, 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 SURGEON WAS REMOVING A PLATE AND 9 SCREWS FROM THIS PATIENT. DURING THE REMOVAL 3 OF THE 3.5MM SCREW HEADS BROKE OFF INTO THE PATIENT. THESE 3 SCREWS REMAINED IN THE PATIENT. HE ALSO REMOVED A PLATE AND 6 SCREWS ALL OF WHICH WERE REMOVED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 7 OF 10 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274510 ↗
• InjuryFeb 3, 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 SURGEON WAS REMOVING A PLATE AND 9 SCREWS FROM THIS PATIENT. DURING THE REMOVAL 3 OF THE 3.5MM SCREW HEADS BROKE OFF INTO THE PATIENT. THESE 3 SCREWS REMAINED IN THE PATIENT. HE ALSO REMOVED A PLATE AND 6 SCREWS ALL OF WHICH WERE REMOVED SUCCESSFULLY. PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WERE SURGICAL DELAY AND PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 3.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 3 OF 10 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273867 ↗
• InjuryJan 7, 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 A HARDWARE REMOVAL DUE TO A MEDIAL TIBIA WOUND, AND THE FRACTURE WAS HEALED. INITIALLY, THE PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) PLATING SYSTEM ON AN UNKNOWN DATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR 1 3.5MM CORTEX SCREW SELF-TAPPING 40MM THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4). ADDITIONAL DEVICE ARE CAPTURED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Impaired Healing

  MAUDE report 11135843 ↗
• InjuryOct 30, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10763550 ↗
• InjuryOct 30, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10762751 ↗
• InjuryOct 30, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10762745 ↗
• 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 TWO (2) CORTEX SCREWS, ONE (1) TITANIUM CANNULATED TIBIAL NAIL-EX WITH PROXIMAL BEND, FOUR (4) TITANIUM LOCKING SCREW AND ONE (1) TITANIUM END CAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW SELF-TAPPING 44MM (PART NUMBER 204.844, 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 ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 40

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

  MAUDE report 10108217 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS FURTHER REPORTED THAT MOST DISTAL SCREW IN LATERAL PLATE. THE SURGEON SAID HE DRILLED PERPENDICULAR TO THE PLATE BUT SCREW SKIVED DISTALLY AND SNAPPED OFF. THERE WAS SURGICAL DELAY FOR UNKNOWN LENGTH OF TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8383703 ↗