NA SD312.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034705804), received between Dec 12, 2016 and Dec 12, 2016 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 12, 2016Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING THE INITIAL ANTERIOR CERVICAL FUSION SURGERY PERFORMED ON (B)(6) 2016 FOR C5-6 & C6-7 LEVELS TO TREAT CERVICAL STENOSIS THE CUSTOM DRILL/TAP AND SCREW (DTS) GUIDE WITH POST SHORT BROKE OFF. THE GUIDE HAS A SMALL POST ON ITS TIP AND IT GOES IN THE PLATE HOLE TO ALIGN THE PLATE FOR SCREW INSERTION. AFTER SCREW INSERTION WHEN SURGEON WAS PULLING OUT THE GUIDE FROM THE PLATE, 1MM TINY LITTLE POST OF THE GUIDE BROKE OFF. THE BROKEN PIECE WAS EASILY RETRIEVED. NO FRAGMENTS REMAINED IN THE PATIENT WAS CONFIRMED THROUGH THE ROUTINE X-RAYS TAKEN DURING THE PROCEDURE. SURGEON USED THE LONG DRILL GUIDE TO COMPLETE THE PROCEDURE. THERE WAS ABOUT 1 MINUTE SURGICAL DELAY DUE TO REPORTED EVENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM, NO ADDITIONAL MEDICAL INTERVENTION. PATIENT OUTCOME POST-SURGERY REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED AS: TITANIUM ANTERIOR CERVICAL COMPRESSION PLATE (PART # 450.536, LOT # UNKNOWN, QUANTITY 1), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6166001 ↗