NA 407.636Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982208415), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE ON (B)(6) 2018, CANNSCR Ø4 SELF-DRILL L36/12 TAN GOLD SCREW ITSELF DAMAGED INSIDE BEFORE USE AND ANOTHER SCREW (SAME SIZE AND MATERIAL) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645461 ↗