NA 02.211.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982053657), received between Oct 18, 2018 and Jun 26, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY ON AN UNKNOWN DATE, THE 2.7 VA LOCKING SCREW BROKE ON INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198220 ↗
• 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 12 OF 17 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090758 ↗
• InjuryAug 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT FUSION SURGERY ON THE FOOT AND WAS IMPLANTED WITH ONE (1) VARIABLE ANGLE- LOCKING COMPRESSION PLATE (VA-LCP) CLOVERLEAF FUSION PLATE, ONE (1) VA-LCP T-FUSION PLATE 2 HOLE HEAD, ONE(1) 4.0MM CANNULATED SCREW LONG THREAD, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 26MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 32MM, AND ONE (1) WASHER. IN LATE 2015, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT AND PAIN WHICH ATTRIBUTED TO HIS OSTEOARTHRITIS AND PREVIOUS FRACTURE. ON (B)(6) 2016, THE PAIN HAD WORSENED. X-RAYS OF THE FOOT WERE TAKEN WHICH SHOWED SEVERAL OF THE UNKNOWN SYNTHES SCREWS IMPLANTED WERE BROKEN. THE PATIENT¿S CLINIC VISITS ON (B)(6) 2016 AND (B)(6) 2017 WERE DUE TO THE PAIN FELT IN THE RIGHT ANKLE. THE PATIENT MET WITH ANOTHER SURGEON FOR A POSSIBLE REVISION, BUT THE SURGEON REFUSED TO PERFORM DUE TO THE RIS

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8898754 ↗
• 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) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM THIS IS REPORT 3 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 8128948 ↗
• InjuryOct 18, 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 28MM THIS REPORT IS 8 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7978321 ↗
• 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 1 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977312 ↗