NA 03.613.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034714547), received between Dec 21, 2016 and Dec 30, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Bent” (5 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL/TAP AND SCREW GUIDE WITH POST WAS SPLAYED OPEN AT THE DISTAL END AND A PIECE WAS BET BEYOND REPAIR BROKE. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A DRILL/TAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120366 ↗
• MalfunctionApr 29, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE SURGEON PLACED THE GUIDE IN THE HOLE OF THE PLATE AND ATTEMPTED TO SEAT IT. THERE WAS A LITTLE TROUBLE DOING THIS HOWEVER, THE PIN WAS SEATED IN THE HOLE OF THE PLATE AND FOUR (4) SCREWS WERE PLACED. AS THE SURGEON LIFTED THE GUIDE OUT OF THE LAST PLACE, THE PIN GOT STUCK AND HAD TO BE REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE (5) MINUTES. CONCOMITANT DEVICES: PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A DRILL/TAP AND SCREW GUIDE WITH POST. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009241 ↗
• MalfunctionOct 5, 2017Break; Break

  DURING AN INITIAL ANTERIOR CERVICAL DECOMPRESSION FUSION (ACDF) PROCEDURE AT C3-4, C4-5, C5-6 ON (B)(6) 2017, WHILE DRILLING A HOLE, THE DRILL TAP/SCREW GUIDE'S LITTLE TIP THAT ENGAGES WITH THE PLATE BROKE OFF. SURGEON REMOVED THE GUIDE THEN REMOVED BROKEN PIECE EASILY. PLATE REMAINS IMPLANTED. ANOTHER DRILL GUIDE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR SURGICAL DELAY. PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICES REPORTED: TITANIUM (TI) VECTRA PLATE 3 LEVEL/48MM (PART 04.613.248, LOT NUMBER UNKNOWN, QUANTITY 1), UNKNOWN DRILL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915645 ↗
• MalfunctionApr 28, 2017Bent; Bent

  THE MALFUNCTIONS FOR ALL OF THE PARTS WERE ASSESSED AND IT WAS DETERMINED ONLY THE BENT DRILL/TAP AND SCREW GUIDE WITH POST MET THE CRITERIA OF A REPORTABLE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6531196 ↗
• MalfunctionMar 1, 2017Bent; Bent

  IT WAS REPORTED THAT THE TIPS OF TWO (2) DRILL/TAP AND SCREW GUIDES WITH POST AND THE FLANGES ARE FOUND BENT ON ANOTHER DRILL/TAP AND SCREW GUIDE WITH POST. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DRILL/TAP AND SCREW GUIDE WITH POST. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6368469 ↗
• MalfunctionMar 1, 2017Bent; Bent

  IT WAS REPORTED THAT THE TIPS OF TWO (2) DRILL/TAP AND SCREW GUIDES WITH POST AND THE FLANGES ARE FOUND BENT ON ANOTHER DRILL/TAP AND SCREW GUIDE WITH POST. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DRILL/TAP AND SCREW GUIDE WITH POST. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6368462 ↗
• MalfunctionMar 1, 2017Bent; Bent

  IT WAS REPORTED THAT THE TIPS OF TWO (2) DRILL/TAP AND SCREW GUIDES WITH POST AND THE FLANGES ARE FOUND BENT ON ANOTHER DRILL/TAP AND SCREW GUIDE WITH POST. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. NO PROCEDURE OR PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) DRILL/TAP AND SCREW GUIDE WITH POST. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6368459 ↗
• MalfunctionDec 21, 2016Bent; Bent

  IT WAS REPORTED THAT A PRONG ON THE END OF A DRILL/TAP AND SCREW GUIDE WAS DISCOVERED BENT IN A SET. THIS WAS FOUND OUTSIDE OF THE OPERATING ROOM AND DOES NOT INVOLVE A PATIENT OR PROCEDURE. THE AGE OF THE DEVICE IS UNKNOWN BUT IT HAS BEEN IN USE FOR APPROXIMATELY 4 YEARS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6194718 ↗