NA 02.211.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982053688), received between Sep 19, 2018 and Dec 24, 2025 — classified as 7 injuries, 2 malfunctions.

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 18, 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.

• MalfunctionDec 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND/OR BENT AND SOME SCREWS WOULD NOT LOCK IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889170 ↗
• 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), THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 15 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090741 ↗
• 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 14 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090636 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE (MM/DD/YYYY): (B)(6) 2020. EXPLANT DATE (MM/DD/YYYY): (B)(6) 2020.

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

  MAUDE report 11230642 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2020 THE IMPLANTS WERE REMOVED.

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

  MAUDE report 11225188 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018, DUE TO A NONUNION AND HARDWARE FAILURE. PATIENT INITIALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY ON (B)(6) 2018, TO TREAT A LEFT DISTAL HUMERUS FRACTURE. THE IMPLANTED DEVICES WERE VARIABLE ANGLE DISTAL HUMERUS PLATE, VARIABLE ANGLE-LCP LAT DISTAL HUMERUS PLATE, EIGHT (8) VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE LOCKING SCREW SELF-TPING WITH T8 STARDRIVE, VARIABLE ANGLE-LCP PROXIMAL OLECRANON, AND FOUR (4) ORTEX SCREW SELF- TAPPING. THE PROCEDURE WAS COMPLETED, AND ALL HARDWARE WAS REMOVED INTACT. THE FRACTURE WAS REDUCED, AND AN UNKNOWN VARIABLE ANGLE ELBOW PLATE WITH UNKNOWN SCREWS WERE USED FOR FIXATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 34 MM THIS IS REPORT 5 OF 10 FOR (B)(4). DUE TO A LIMIT OF IMPACTED PRODUCTS PER COMPLAINT, THIS COMPLAINT IS A CONTINUATION FROM COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8129161 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO PAIN. DURING THE PROCEDURE, FIVE (5) VARIABLE ANGLE (VA) LOCKING SCREWS WERE BROKEN. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED. NO ADDITIONAL HARDWARE WAS PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. REVISION SURGERY DUE TO PAIN IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE INTRAOPERATIVE ISSUE WITH BROKEN SCREWS. CONCOMITANT DEVICES: 3.5MM CORTEX SCREW 22MM (PART 204.822, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW 24MM (PART 204.824, LOT UNKNOWN, QUANTITY 2), 3.5MM CORTEX SCREW 30MM (PART 204.830, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW 16MM (PART 204.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW 12MM (PART 204.812, LOT UNKNOWN, QUANTITY 2), 3.5MM LOCKING SCREW 10MM (PART 212.101, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW 14MM (PART 212.103, LOT UNKNOWN, QUANTITY 1), LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 69MM (PART 241.361, LOT H398866, QUANTITY 1), 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE-RIGHT (PART 02.118.004, LOT 9512579, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977478 ↗
• InjuryOct 17, 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 A HARDWARE REMOVAL PROCEDURE DUE TO PAIN. THERE WERE (1) LOCKING COMPRESSION PLATE (LCP) TUBULAR PLATE WITH COLLAR, ONE (1) VARIABLE ANGLE LCP MEDIAL DISTAL TIBIA PLATE, SEVEN (7) CORTEX SCREWS, TWO (2) LOCKING SCREWS WITH STARDRIVE AND FIVE (5) VARIABLE ANGLE LOCKING SCREWS WITH T8 STARDRIVE WERE REMOVED. THE HARDWARE WAS IMPLANTED ON AN UNKNOWN DATE. DURING THE PROCEDURE THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS BROKE. THE BROKEN SCREWS WERE FULLY REMOVED. THE BONE WAS HEALED AND NO ADDITIONAL HARDWARE WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL SIX DEVICES THIS COMPLAINT INVOLVES TEN 10 OF THE 16 DEVICES. THIS COMPLAINT IS FOR ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 34MM. THIS REPORT IS 10 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7976019 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL SURGERY DUE TO WOUND BREAKDOWN ON (B)(6) 2018. FOUR (4) SELF TAPPING METAPHYSEAL SCREWS, FOUR (4) VARIABLE ANGLE (VA) SELF TAPPING LOCKING SCREWS, ONE (1) VA LARGE LOCKING CALCANEAL PLATE, ONE (1) SELF TAPPING CORTEX SCREW WERE REMOVED. ONE (1) SELF TAPPING CORTEX SCREW REMAINED IMPLANTED DUE TO UNKNOWN REASON. ORIGINAL IMPLANT DATE IS ON (B)(6) 2018. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 5 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Erosion; Not Applicable

  MAUDE report 7891843 ↗