N/A 8450107530Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327097023), received between Jun 15, 2018 and Feb 20, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399771 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163979 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399941 ↗
• MalfunctionFeb 9, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE OVERHEATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676928 ↗
• MalfunctionFeb 9, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE OVERHEATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676786 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992803 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398980 ↗
• MalfunctionFeb 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A MICRODISCECTOMY PROCEDURE, THE BUR BROKE AT THE SHAFT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416230 ↗
• MalfunctionNov 7, 2022Fracture; Fracture

  IT WAS REPORTED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT, A BROKEN BUR WAS OBSERVED INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748874 ↗
• MalfunctionOct 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628690 ↗
• MalfunctionAug 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237221 ↗
• MalfunctionMay 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING, THE BUR BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365225 ↗
• MalfunctionMay 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING, THE BUR BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14365191 ↗
• MalfunctionMar 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A MICRODISCECTOMY SURGICAL PROCEDURE, TWO BURS BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688764 ↗
• MalfunctionMar 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A MICRODISCECTOMY SURGICAL PROCEDURE, TWO BURS BROKE IN TWO ATTACHMENTS. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688715 ↗
• MalfunctionSep 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A MIS (MINIMALLY INVASIVE SPINE) PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533367 ↗
• MalfunctionSep 3, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL FUSION PROCEDURE, THE BUR BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422441 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINE SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A TWO MINUTE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546042 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS DELAY BY A FEW MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393595 ↗
• MalfunctionSep 17, 2020Fracture; Fracture

  IT WAS REPORTED VIA A MEDWATCH REPORT (B)(4) THAT, DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECES WERE RECOVERED FROM THE SURGICAL SITE. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10550597 ↗
• MalfunctionJul 14, 2020Break

  DOCTOR WAS DRILLING THE PATIENTS BONE WITH THE PRECISION MATCH HEAD 3.0 MM, IT SNAPPED OFF AND BROKE IN THE PATIENTS BONE. WE RETRIEVED THE PIECES OUT OF PATIENTS BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10270163 ↗
• MalfunctionSep 10, 2018Break; Break

  IT WAS REPORTED THAT DURING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE, THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859657 ↗
• MalfunctionJun 15, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BUR BROKE INSIDE THE ATTACHMENT AND REMAINED STUCK IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. A MINOR DELAY OF 3 TO 4 MINUTES WAS REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7607430 ↗