NA 02.211.044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982053732), received between Feb 25, 2021 and Mar 20, 2023 — classified as 2 injuries, 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 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 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER OF 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLING, 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 44 THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16572158 ↗
• InjuryJul 8, 2022Material Deformation; Material Deformation

  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 4 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 14955077 ↗
• MalfunctionFeb 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. INTRA-OPERATIVELY, SOME OF THE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 HOLES/RIGHT (PART # 02.118.210, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1)2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 44MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381814 ↗