Vault C ACDF System 37-IN-0060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840019916974), received between Nov 19, 2019 and Jan 9, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2025, UTILIZING THE VAULT C ACDF SYSTEM. DURING THE PLACEMENT OF THE SUPERIOR SCREW, AN AWL WAS USED TO INITIATE THE SCREW TRAJECTORY. A SCREWDRIVER WITH A SIZE 14 SCREW WAS THEN USED. AT THIS POINT, THE TIP OF THE SELF-RETAINING DRIVER (37-IN-0060) BROKE. THE FRACTURED TIP WAS SUCCESSFULLY REMOVED FROM THE SCREW. A SECOND SCREWDRIVER WAS THEN USED, ALLOWING FOR THE PROPER PLACEMENT OF BOTH THE SUPERIOR AND INFERIOR SCREWS, BOTH SIZE 14. THERE WAS A TWO-MINUTE DELAY TO THE PROCEDURE BUT NO INJURY TO THE PATIENT AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028937 ↗
• InjuryApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN THE DOMINICAN REPUBLIC ON (B)(6) 2024, UTILIZING THE VAULT C ACDF SYSTEM. AFTER PREPARING THE DISC SPACE, THEY USED A RASP TO REFINE THE ENDPLATE. FOLLOWING THAT, THEY INSERTED THE IMPLANT INTO THE DISC AND PREPARED THE SCREW HOLE. THEY UTILIZED A STRAIGHT AWL AND THEN A STRAIGHT DRILL. WHILE ATTEMPTING TO INSERT A SCREW, THE TIP OF THE SELF-RETAINING DRIVER (B)(6) BROKE. THE TIP WAS UNABLE TO BE REMOVED FROM THE HEAD OF THE SCREW SO THE SCREW WAS REMOVED AND REPLACED UTILIZING THE ANGLED DRIVER READILY AVAILABLE IN THE SET. THERE WAS A ONE (1) MINUTE DELAY TO THE PROCEDURE DUE TO THE MALFUNCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060840 ↗
• InjuryFeb 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2024, UTILIZING THE VAULT C ACDF SYSTEM. UPON ATTEMPTED INSERTION OF A SCREW, THE SELF-RETAINING DRIVER (37-IN-0060) TIP BROKE. THE SCREW WAS ONLY PARTIALLY INSERTED WHEN THE TIP BROKE, ALLOWING REMOVAL OF THE SCREW WITH A PAIR OF PLIERS. A SECOND SCREW WAS READILY AVAILABLE IN THE SET AND WAS SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS A ONE (1) MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773353 ↗
• MalfunctionAug 16, 2021Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2021, UTILIZING THE DAKOTA ACDF STANDALONE CERVICAL SYSTEM. DURING THE PROCEDURE THE FIRST SCREW WENT IN FINE AND THEN UPON IMPLANTING THE SECOND SCREW THE TIP OF THE SELF-RETAINING DRIVER (37-IN-0060) BROKE. THIS OCCURRED AS HE WAS DRIVING THE LAST ONE OR TWO THREADS. IT WAS NOTED THAT THE SCREW WAS AT A HIGH ANGLE AND PLACED FREEHAND (NO INSERTER), SO IT IS POSSIBLE THAT IT COULD HAVE BEEN BEYOND THE 45 DEG. THAT THE IMPLANT ALLOWS. THERE MAY HAVE BEEN SOME SCREW AND INTERBODY INTERFERENCE, CAUSING THE DIFFICULTY IN INSERTING THE SCREW, AS WELL AS EXTREMELY HARD BONE. THERE WAS NO AWL OR DRILL USED PRIOR TO SCREW INSERTION. THE BROKEN TIP WAS SUCTIONED AWAY, AND DUE TO THE DOCTOR'S OPINION THAT THE SCREW WAS TOO LONG, THE SCREW WAS REMOVED AND REPLACED WITH A RESCUE SCREW WITH NO FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12327820 ↗
• MalfunctionMay 24, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED UTILIZING THE VAULT C ACDF SYSTEM. UPON INSERTION OF ONE OF THE SCREWS THE SELF-RETAINING DRIVER (37-IN-0060) TIP BROKE OFF. THE DOCTOR WAS ABLE TO REMOVE THE TIP PIECES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INJURY TO THE PATIENT. THERE WAS A DELAY OF FIVE (5) MINUTES BECAUSE OF THE DRIVER MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872066 ↗
• MalfunctionNov 12, 2020Break

  IT WAS REPORTED THAT DURING ACDF SURGERY ON (B)(6) 2020, PERFORMED IN DUBAI, THE SURGEON WAS USING THE SELF-RETAINING DRIVER (37-IN-0060) TO INSERT THE SCREW WHEN THE TIP OF THE SCREW DRIVER BROKE INSIDE THE BODY OF THE PATIENT AND THE SCREW FELL FROM THE SCREW DRIVER. THE SURGEON WAS ABLE TO REMOVE THE BROKEN TIP AND USE THE SECOND DRIVER IN THE SET TO INSERT THE SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY BUT A 30 MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10829938 ↗
• InjuryMar 12, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON OR AROUND (B)(6) 2020, IN (B)(6), THE TIP OF THE SELF-RETAINING DRIVER (37-IN-0060) BROKE WHEN THE SCREW WAS APPROXIMATELY 2/3RDS OF THE WAY SEATED. THE BROKEN TIP REMAINED IN THE SCREW, WHICH WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND A NEW SCREW INSERTED UTILIZING THE ANGLED DRIVER WHICH WAS READILY AVAILABLE IN THE SET. THERE WAS NO PATIENT ISSUES REPORTED BUT, THERE WAS A DELAY TO THE PROCEDURE OF APPROXIMATELY 30 MINUTES AS A RESULT. IT WAS NOTED THAT THE BONE WAS PREPPED ONLY WITH AN AWL PRIOR TO ATTEMPTED SCREW INSERTION, NO TAP WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9825409 ↗
• InjuryMar 12, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED IN THE DOMINICAN REPUBLIC, ON (B)(6) 2020, UTILIZING THE VAULT C ACDF SYSTEM. AFTER PLACING THE FIRST SCREW GOING UPWARDS, THE SURGEON WAS PLACING THE LOWER SCREW AND WHILE TRYING TO PUSH IN, THE TIP OF THE SELF-RETAINING DRIVER (37-IN-0060) BROKE AND STAYED IN THE HEAD OF THE SCREW SO THE SCREW WAS REMOVED AND REPLACED. THE ANGLED DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO THE PROCEDURE OF TWENTY (20) MINUTES AS A RESULT. NO HARM TO THE PATIENT WAS REPORTED. THE BONE WAS ONLY PREPPED WITH AN AWL, A TAP WAS NOT USED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9825245 ↗
• MalfunctionFeb 10, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT A ONE LEVEL ACDF CASE WAS PERFORMED ON (B)(6) 2020, UTILIZING THE VAULT C ACDF INTERBODY SYSTEM. THE DOCTOR WAS TRYING TO REPOSITION AND ADJUST THE DEPTH OF THE SCREW WHEN THE TIP OF THE SELF-RETAINING DRIVER (37-IN-0060) BROKE IN THE HEAD OF THE SCREW. THE TIP WAS ABLE TO BE REMOVED WITH A HEMOSTAT AND THE PROCEDURE WAS COMPLETED UTILIZING THE SECOND DRIVER READILY AVAILABLE IN THE SET. THERE WAS A DELAY OF APPROXIMATELY 7-8 MINUTES WITH NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687686 ↗
• MalfunctionNov 19, 2019Break

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2019, IN THE DOMINICAN REPUBLIC, UTILIZING THE VAULT C ACDF SYSTEM. AFTER PLACING THE FIRST SCREW THE SURGEON WAS PLACING THE LOWER SCREW AND WHILE TRYING TO PUSH THE SCREW IN, THE TIP BROKE AND WAS LEFT IN THE SCREW. THE BROKEN TIP PIECE WAS ABLE TO BE REMOVED AND THE SCREW WAS REMOVED AND REPLACED, RESULTING IN A DELAY TO THE PROCEDURE OF THIRTY (30) MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9341540 ↗