NA 02.211.046Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982053749), received between Jul 9, 2018 and Mar 17, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON APRIL OF 2021 THE PATIENT WAS IMPLANTED WITH SYNTHESE DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 46 THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16568851 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, THAT PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION AND 1 BROKEN 60MM LENGTH VA LOCKING SCREW. ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, SEVEN (7) VA LOCKING SCREWS AND ONE (1) CORTEX SCREW AND ONE (1) VA LCP DISTAL HUMERUS PLATE WERE SUCCESSFULLY EXPLANTED. THERE WAS A FRAGMENT OF THE SHAFT AND THE SCREWHEAD BUT IT WAS REMOVED EASILY WITHOUT ADDED TIME. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10755183 ↗
• 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 7 OF 7 FOR COMPLAINT (B)(4)

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

  MAUDE report 7671665 ↗