N/A 5820107530CRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613327294989), received between Apr 30, 2018 and Oct 28, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Fracture” (22 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• 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 4 EVENTS FOR THE FAILURE: FRACTURE. - 4 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399956 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  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 22647017 ↗
• MalfunctionNov 20, 2024

  DURING THE SURGERY, ONE OF THE STRYKER CARBIDE MATCH HEAD/BUR WITH REF OF 5820-107-530C LOT# 24193047 GOT BROKEN AND THE TIP OF THE BUR GOT RECOVERED BUT THERE ARE SOME FRAGMENTS STAYED IN THE BODY DUE TO ITS MICROSCOPIC SIZE, SURGEON DID X-RAY AND HE'S AWARE OF IT AND DECIDED TO CLOSE THE SURGICAL SITE BECAUSE THERE'S NO WAY TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20733352 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT. 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED. 1 EVENT REQUIRED IMAGING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500745 ↗
• MalfunctionSep 27, 2024

  DURING THE SURGICAL PROCEDURE, THE CARBIDE DRILL BIT TIP WAS BROKEN OFF WHILE SURGEON WAS USING THE DRILL. DOCTOR NOTICED IMMEDIATELY AND SEARCHED THE SURGICAL FIELD FOR THE TIP. THE TIP WAS NOT FOUND ON OR AROUND THE SURGICAL FIELD. DOCTOR USED FLUOROSCOPY (C-ARM) TO SEARCH FOR THE TIP IN THE SURGICAL WOUND. NO METAL TIP PIECE WAS SEEN ON X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320858 ↗
• MalfunctionApr 15, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113292 ↗
• MalfunctionApr 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755808 ↗
• MalfunctionDec 13, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971046 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BUR BROKE. 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 15880285 ↗
• MalfunctionOct 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A FUSION ON THE DECOMPRESSION PROCEDURE, THE BUR BROKE AT THE TIP. 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 15610684 ↗
• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINAL 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 15362195 ↗
• MalfunctionMay 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DISTAL END OF THE BUR BROKE DURING A MINIMALLY INVASIVE DECOMPRESSION SURGICAL PROCEDURE. IT WAS ALSO REPORTED THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES TO SWITCH OUT DEVICES. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 14342297 ↗
• MalfunctionMay 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DISTAL END OF THE BUR BROKE DURING A MINIMALLY INVASIVE DECOMPRESSION SURGICAL PROCEDURE. IT WAS ALSO REPORTED THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES TO SWITCH OUT DEVICES. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 14342181 ↗
• MalfunctionApr 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THORACOLUMBAR SPINE REVISION/FUSION, THE BUR BROKE IN MULTIPLE LOCATIONS. 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 14161738 ↗
• MalfunctionJan 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BUR WAS BROKEN INSIDE THE PACKAGING WHEN IT WAS RECEIVED AT THE FACILITY. 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 13385764 ↗
• MalfunctionNov 22, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BUR DID NOT CUT THE BONE DURING A LUMBAR FUSION. IT WAS FURTHER REPORTED THAT THE BUR WAS HEATING UP AND SMOKING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853651 ↗
• MalfunctionOct 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION LUMBAR PROCEDURE, THE TIP OF THE BUR BROKE OFF UPON CONTACT WITH A METAL PLATE. IT WAS ALSO REPORTED THAT THE METAL PLATE WAS FROM A PREVIOUS SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT AN MRI WAS ADMINISTERED TO LOCATE BROKEN TIP. IT WAS ALSO REPORTED THAT THE TIP OF THE BUR WAS NOT FOUND. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF FIVE MINUTES 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 12616123 ↗
• MalfunctionJun 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT AT THE END OF A SURGICAL PROCEDURE, THE BUR BROKE AND STUCK INSIDE THE ATTACHMENT. 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 12021085 ↗
• MalfunctionMar 8, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440197 ↗
• MalfunctionAug 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PREPARATION FOR A SURGERY, THE BUR WAS BROKEN IN THE PACKAGE. 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; No Patient Involvement

  MAUDE report 10363098 ↗
• MalfunctionMar 24, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, PARTICLES WERE IDENTIFIED IN THE PACK PRIOR TO A PROCEDURE. 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; No Patient Involvement

  MAUDE report 9875377 ↗
• MalfunctionMar 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINE FUSION PROCEDURE, TWO BURS BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THE BURS HAD CONTACT WITH METAL RETRACTORS. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF SEVERAL MINUTES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866830 ↗
• MalfunctionMar 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINE FUSION PROCEDURE, TWO BURS BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THE BURS HAD CONTACT WITH METAL RETRACTORS. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF SEVERAL MINUTES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866828 ↗
• MalfunctionDec 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT A DELAY OF 2 MINUTES WAS CAUSED BY THE EVENT. IT WAS FURTHER REPORTED THERE WERE NO ADVERSE CONSEQUENCES 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 9475365 ↗
• MalfunctionOct 1, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE HEAD OF THE BUR BROKE DURING A POSTERIOR CERVICAL FUSION PROCEDURE. IT WAS ALSO REPORTED THAT THE FRAGMENT REMAINS IN THE PATIENT. IT WAS FURTHER REPORTED THAT 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 Consequences Or Impact To Patient

  MAUDE report 9139856 ↗