NA 02.211.058Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982053800), received between Dec 4, 2018 and Apr 6, 2023 — classified as 1 injury, 1 malfunction.

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

• MalfunctionApr 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE USED DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OLECRANON PROCEDURE ALONG WITH THE PRODUCT 2.7/3.5 VA-LCP PROXIMAL OLECRANON PLATE. ONE OF THE PROXIMAL HOLES WAS INITIALLY FILLED WITH A 2.7 METAPHYSEAL SCREW FOR INITIAL FIXATION AND REPLACED WITH THE 2.7 VA LOCKING SCREW AND AN ADDITIONAL SCREW INTO THE TWO MOST PROXIMAL HOLE IN THE PLATE. NEITHER OF THESE SCREWS WOULD LOCK INTO THE PLATE. THE SURGEON TRIED TWICE AND WAS FRUSTRATED BECAUSE THIS LOCKING TECHNOLOGY WAS CRUCIAL TO THE FRACTURE PATTERN AND PATIENT BONE QUALITY. THE SCREWS WERE REMOVED AND REPLACED WITH ALTERNATIVE SCREWS BUT THEY ALSO DID NOT LOCK AS THEY NORMALLY WOULD. THE SCREWS WERE RETRIEVED AND THE SCRUB TECHNICIAN ATTEMPTED TO LOCK THEM INTO A REMOVED PLATE AND THEY WOULD NOT FULLY SEAT OR LOCK. ALL SURGICAL TECHNIQUES WERE FOLLOWED. IT WAS UNKNOWN WHETHER THERE WAS ANY PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 58MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690129 ↗
• 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 58MM THIS IS REPORT 9 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 8129472 ↗