NA 02.211.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982053671), received between Jul 9, 2018 and Feb 6, 2023 — classified as 6 injuries, 5 malfunctions.

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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2023, SURGEON WAS PUTTING IN A 2.7MM VA LOCKING SCREWS INTO A 4H LEFT VA LCP OLECRANON PLATE. WHILE INSERTING THE SCREW THE THREADS OF THE SCREW CAME OFF. SURGEON FOLLOWED ALL APPROPRIATE STEPS TO INSERT THE SCREW. SURGEON WAS UNSURE IF SCREW HEAD LOCKED INTO THE PLATE DUE TO THE PATIENTS GOOD BONE QUALITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 32. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308973 ↗
• MalfunctionJan 25, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE SCHEDULED OR CASE FOR REMOVAL OF THE RIGHT ELBOW, 2 OF THE SCREWS WERE UNABLE TO BE REMOVED AS THE HEADS OF THE SCREWS BROKE DURING THE REMOVAL PROCESS. THE BODY OF THE SCREWS WERE UNABLE TO BE RETRIEVED, AND IT WAS DECIDED TO LEAVE THE REMAINING PARTS OF THE SCREWS IMPLANTED IN BONE. THERE WAS A SURGICAL DELAY, AND UNKNOW OF SURGERY OUTCOME, PATIENT DISCHARGED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 32. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244473 ↗
• MalfunctionNov 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A DISTAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2020, TWO (2) 2.7 VARIABLE ANGLE LOCKING SCREWS DID NOT LOCK INTO THE LATERAL DISTAL HUMERUS PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF 2.7 METAPHYSEAL SCREWS. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR A 2.7 VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824474 ↗
• 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 8898759 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO PAIN ON (B)(6) 2018. HARDWARE REMOVED DURING THE PROCEDURE INVOLVES ONE (1) LOCKING COMPRESSION PLATE (LCP) ONE-THIRD 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. 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 IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT ADDRESSES THE REVISION SURGERY DUE TO PAIN. ADDITIONAL PRODUCTS INVOLVED ARE ADDRESSED IN (B)(4). THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREWS IS ADDRESSED IN (B)(4). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7978592 ↗
• 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 32MM THIS REPORT IS 9 OF 10 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7978305 ↗
• 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 3 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977469 ↗
• 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 2 OF 5 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7977463 ↗
• 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 10 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Erosion; Not Applicable

  MAUDE report 7891878 ↗
• 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 4 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Erosion; Not Applicable

  MAUDE report 7891833 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY OF THE OLECRANON ON (B)(6) 2018 TO FIX THE HUMERUS. THE OSTEOTOMY WAS REPAIRED WITH AN OLECRANON PLATE, 2 CORTEX SCREWS, AND 4 VARIABLE ANGLE (VA) LOCKING SCREWS. ON (B)(6) 2018 THE PATIENT HAD A REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO NON-UNION. IT WAS NOTED THAT THE PROXIMAL OLECRANON DID NOT HEAL AND THE PIECE OF BONE CAME OUT OF THE SCREW PLATE CONSTRUCT, AND PATIENT ALSO EXPERIENCED MALUNION AND DECREASED RANGE OF MOTION. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS' PROXIMAL OLECRANON WAS REMOVED AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7671569 ↗