N/A 6971118Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994296085), received between Jul 9, 2021 and Sep 2, 2026 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50559735 ↗
• MalfunctionJun 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR (DIS), HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT C3-5 DISCECTOMY AND FUSION SPINAL THERAPY FOR C3-5 HIVD. IT WAS REPORTED THAT THE TIP OF THE CUTTER DRILL BIT WAS BROKEN. NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601036 ↗
• MalfunctionApr 6, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A DISTRIBUTOR AND MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A PRESTIGE IMPLANT USING A DRILL BIT IN A TOTAL DISC REPLACEMENT FOR A C4-5 OPLL. IT WAS REPORTED THAT AFTER INSERTING THE PRESTIGE TRIAL, THE SURGEON DECIDED THE SIZE OF THE IMPLANT AND PREPARED TO DRILL THE HOLE. THE SURGEON USED THE BONE RONGEUR TO REMOVED A PARTIAL SPUR OF THE ANTERIOR BODY. WHILE THE DOCTOR DRILLED THE 3RD HOLE, HE FELT THAT THE DRILL JAMMED. HE SCREWED IT OUT AND THE DRILL WAS BROKEN. HE REMOVED THE BROKEN TIP AND REPLACED THE NEW DRILL TO FINISH THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14020642 ↗
• MalfunctionFeb 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING RAIL CUTTER DRILL BITS IN A C5/6 ARTHROPLASTY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE RAIL CUTTER DRILL BITS BROKE DURING SURGERY AND THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. DRILL BITS WERE IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13617530 ↗
• MalfunctionFeb 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING RAIL CUTTER DRILL BITS IN A C5/6 ARTHROPLASTY FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE RAIL CUTTER DRILL BITS BROKE DURING SURGERY AND THERE WERE NO FRAGMENTS OF THE INSTRUMENTS REMAINING IN THE PATIENT'S BODY. DRILL BITS WERE IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13617520 ↗
• MalfunctionJul 9, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN UNKNOWN INDICA TION FOR DISC ARTHROPLASTY. IT WAS REPORTED THAT THE DRILL TIP BROKE WHEN DRILLING RAIL CUTS. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT PRE-OP DIAGNOSIS WAS CERVICAL SPINE DEGENERATION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141650 ↗