NA 414.826Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982213631), received between Aug 13, 2018 and Jun 26, 2020 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJun 26, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE CUSTOMER RECEIVED OF AN EMPTY BAG WITHOUT ANY PRODUCT INSIDE. NO PATIENT IMPACT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10202362 ↗
• InjuryAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2018, SURGERY FOR IMPLANT REMOVAL WAS PERFORMED. DURING THE SURGERY, A SCREW BROKE AND A PIECE OF THE SCREW SHAFT REMAINED INSIDE THE PATIENT¿S BODY. WHILE REMOVING THE BROKEN PIECE OF THE SCREW USING A REMOVAL TOOL, PART OF THE CORTICAL BONE WAS CUT, AND EXCESSIVE BLEEDING OCCURRED. THE SURGEON BELIEVES THAT THE BROKEN SCREW WAS CAUSED BY THE APPLICATION OF EXCESSIVE FORCE. THE SURGERY WAS COMPLETED WITH A 30-MINUTE DELAY. THE PATIENT IS CURRENTLY VISITING THE HOSPITAL REGULARLY. THIS REPORT IS FOR A 4.5MM TITANIUM (TI) CORTEX SCREW SELF-TAPPING 26MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 7777580 ↗