NA 02.211.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982053640), received between Mar 22, 2018 and Feb 6, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 8 most recent of 8 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 26 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308964 ↗
• MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING PROCEDURE OF DISTAL TIBIAL OSTEOTOMY, THE SCREW WOULD NOT THREAD LOCK INTO THE T-HOLE RIGHT SIDE. THE SCREW WAS REMOVED WITH NEEDLE HOLDER AND REPLACED WITH A METAPHYSEAL SCREW. THERE WAS SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579135 ↗
• 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 26. THIS IS REPORT 10 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860698 ↗
• 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 26. THIS IS REPORT 5 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860364 ↗
• 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 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10824333 ↗
• MalfunctionMay 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: UNKNOWN HEX LOW PROFILE SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587148 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO (2) MIDFOOT/FOREFOOT VARIABLE ANGLE LOCKING SCREWS DUE TO SCREWS ARE BACKED OUT AND ARE APPARENTLY VISIBLE. PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS AND WITHOUT ANY SURGICAL DELAY. NONE OF THE PRE, POST OR INTRA-OPERATIVE X-RAYS FROM INITIAL OR REVISION SURGERY ARE AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7361913 ↗
• InjuryMar 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TWO (2) MIDFOOT/FOREFOOT VARIABLE ANGLE LOCKING SCREWS DUE TO SCREWS ARE BACKED OUT AND ARE APPARENTLY VISIBLE. PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS AND WITHOUT ANY SURGICAL DELAY. NONE OF THE PRE, POST OR INTRA-OPERATIVE X-RAYS FROM INITIAL OR REVISION SURGERY ARE AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7361908 ↗