NA 02.211.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982053633), received between Apr 2, 2019 and Oct 20, 2022 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING A 2.7 VA LOCKING SCREW INTO AN ANTERIOR CLAVICLE PLATE, THE SCREW DID NOT LOCK INTO THE PLATE. THE SURGEON COMMENTED THAT HE DRILLED OUTSIDE OF THE 30 CONE WHICH LIKELY LED TO THE SCREW NOT LOCKING. NO ADVERSE EVENTS OCCURRED IN THIS CASE, AND THE SURGEON HAD NO ALLEGATIONS AGAINST THE PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE IS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639187 ↗
• InjuryJul 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THERE WAS LACK OF LOCKING OF 2.7 MM LOCKING SCREWS IN TWO (2) LOW COMPRESSION PLATE (LCP) ELBOW PLATES WITH A DYNAMOMETRIC SCREWDRIVER INTRAOPERATIVELY. SEVERAL SCREWS BENT AND THERE WERE TWO (2) EDGES ON ONE SIDE. THE PATIENT WAS IMMOBILIZED FOR TEN (10) DAYS AND X-RAYS WERE TAKEN. A SURGICAL REVISION IS PLANNED TO REMOVE EVERYTHING BUT HAS NOT YET BEEN COMPLETED. IMPLANTS ARE STILL CURRENTLY IMPLANTED IN THE PATIENT. THIS IS REPORT 12 OF 12 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

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

  MAUDE report 15074442 ↗
• 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 4 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14089924 ↗
• 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 3 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14089837 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON OR ABOUT (B)(6) 2019 THE PATIENT HAD OPEN REDUCTION ULNAR FRACTURE PROXIMAL END WITH INTERNAL FIXATION OF HIS RIGHT ELBOW. ON OR ABOUT (B)(6) 2020 PATIENT WAS ADMITTED AND HAD AN INCISION, DRAINAGE, AND TREATMENT FOR INFECTION FROM HIS SURGICAL SITE. ON OR ABOUT (B)(6) 2021, THE PATIENT'S INFECTED HARDWARE WAS REMOVED FROM HIS BODY. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 24. THIS IS REPORT 6 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860483 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT RADIAL HEAD REVISION RECONSTRUCTION, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT AND WAS IMPLANTED WITH A NON-SYNTHES DEVICE DUE TO A RIGHT ELBOW RADIAL HEAD REPLACEMENT FAILURE, SYMPTOMATIC HARDWARE WITH STIFFNESS AND INCREASING PAIN. ON (B)(6) 2015, THE PATIENT HAS PRESENTED DISCOMFORT WITH PAIN OVER THE RIGHT ELBOW WHICH RADIATES TO THE RIGHT ELBOW. THE PATIENT FELL DOWN ON HER ELBOW AND SUSTAINED A FRACTURE DISLOCATION. SHE ALSO HAD NERVE SYMPTOMS MOSTLY IN THE ULNAR DISTRIBUTION. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT OLECRANON OPEN REDUCTION INTERNAL FIXATION, RADIAL HEAD RESECTION WITH RADIAL HEAD REPLACEMENT AND OPEN REDUCTION OF RADIAL HEAD AND WAS IMPLANTED WITH DEPUY SYNTHES 20MM DIAMETER HEAD AND A 4 HOLE LONG RIGHT OLECRANON PLATE. THE PATIENT WAS DIAGNOSED WITH RIGHT ELBOW FRACTURE-DISLOCATION, RADIAL HEAD OLECRANON COMMINUTED FRACTURE AND ULNAR NEURAPRAXIA. ON (B)(6) 2016, CT RIGHT UPPER EXTREMITY SHOWS PLATE AND SCREW FIXATION OF THE PROXIMAL ULNA. COMMINUTED INTRA-ARTICULAR FRACTURE NOW WITH BRIDGING CALLUS FORMATION. BRIDGING CALLUS FORM

  Patient problems: Bone Fracture(s); Muscular Rigidity; Pain

  MAUDE report 11252452 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO LEFT ELBOW MONTEGGIA FRACTURE DISLOCATION WITH ULNAR NONUNION, STATUS POST BONE GRAFTING WITH NOW PAINFUL DEEP HARDWARE, POSSIBLE DELAYED UNION, AS WELL AS ULNAR NERVE COMPRESSION. ON (B)(6) 2017, THE PATIENT UNDERWENT A SURGERY AND WAS DIAGNOSED WITH NONUNION LEFT PROXIMAL ULNA STATUS POST OPEN REDUCTION INTERNAL FIXATION MONTEGGIA FRACTURE SUBLUXATION AND WAS IMPLANTED WITH A SYNTHES PLATE AND SCREWS. CONCOMITANT DEVICES REPORTED: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCK SCREW SLF-TAP (PART NUMBER 02.211.036, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM (PART NUMBER 02.211.040, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM. THIS IS REPORT 3 OF 5 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), CAPTURES THE REMAINING FIVE (5) OUT OF FIFTEEN (15) DEVICES. (B)(4) CAPTURES THE FIRST TEN (10) DEVICES OF THE THIRD REVISION. (B)(4

  Patient problems: Bone Fracture(s); Nerve Damage; No Code Available; Pain

  MAUDE report 10441915 ↗
• 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) 4.0 MM CANNULATED SCREW LONG THREAD, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STAR DRIVE RECESS 26 MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STAR DRIVE RECESS 28 MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STAR DRIVE RECESS 14 MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STAR DRIVE RECESS 20 MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STAR DRIVE RECESS 24 MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STAR DRIVE RECESS 32 MM, 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 D

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

  MAUDE report 8898760 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH STARD

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692306 ↗
• InjuryApr 2, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REMOVAL OF A VARIABLE ANGLE (VA) LOCKING SCREW SELF-TAPPING THAT BROKE POSTOPERATIVELY IN THE VA LOCKING COMPRESSION PLATE (LCP). SURGEON HAD THE SCREW OUT AND MADE A HOLE TO DO THAT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT HARM REPORTED. CONCOMITANT DEVICE REPORTED: 2.7MM/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (PART # 02.107.412S, LOT# 7442019, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 8474659 ↗