NA 02.200.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982047960), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 45MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17246420 ↗