NA 03.617.916Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034717234), received between Dec 13, 2016 and Dec 23, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THAT DURING THE SURGERY, THE DRILL BIT WAS BROKE OFF WHILE DRILLING THE SCREW HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY REPORTED. THERE WERE NO FRAGMENTS ARE GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.0MM DRILL BIT WITH 16MM STOP THIS REPORT IS 1 OF 1 FOR PC (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069059 ↗
• MalfunctionJan 8, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ANTERIOR CERVICAL DECOMPRESSION AND FUSION, WHILE DRILLING THROUGH AN UNKNOWN ZERO-P NATURAL PLATE, THE TIP OF THE DRILL BIT BROKE OFF AND THE BROKEN FRAGMENT WAS RETRIEVED IMMEDIATELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT REPORTED. THERE WAS ANOTHER DRILL BIT USED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ZERO-P PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT WITH 16MM STOP QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565905 ↗
• InjuryNov 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TIP OF DRILL BIT BROKE OFF IN PLACE OF PATIENT'S C7 SCREW. SURGEON DETERMINED TO LEAVE THE TIP OF THE DRILL BIT IN PLACE, IN BEST INTEREST OF PATIENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN HANDLE WITH QUICK COUPLING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9292746 ↗
• InjuryOct 17, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING A 2 LEVEL CERVICAL FUSION SURGERY ON AN UNKNOWN DATE TO TREAT THE DEGENERATIVE DISEASE, THE 16 MM DRILL BROKE INSIDE THE PATIENT WHILE THE SURGICAL TEAM DRILLED THE HOLE TO ACCOMMODATE A SCREW. FRAGMENT WAS GENERATED, HOWEVER IT WAS REMOVED EASILY. THE SURGEON USED A SHORTER DRILL BIT TO COMPLETE THE PROCEDURE. THERE WAS SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN HANDLE ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.0MM DRILL BIT WITH 16MM STOP QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9204962 ↗
• MalfunctionDec 13, 2016Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED ON (B)(6) 2016, REPORTED DEVICES BROKE DURING THE INITIAL SURGERY. NO DELAY TO SURGERY TIME WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6171567 ↗