NA 5820107530Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613154028177), received between Oct 24, 2018 and Oct 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 28, 2023Open, Classified

   There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

   Z-0982-2025 · Root cause: Process control · FDA record ↗

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.

• MalfunctionOct 28, 2025Flaked; Flaked

  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: FLAKED. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399875 ↗
• MalfunctionOct 2, 2025Material Disintegration; Material Disintegration

  IT HAS BEEN DETERMINED THAT THIS RECORD IS NOT REPORTABLE. IT IS A DUPLICATE OF AN EVENT REPORTED IN VMSR SUBMISSION (MFR REPORT # 3015967359-2025-99384).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23198696 ↗
• MalfunctionAug 19, 2022Fitting Problem; Device Dislodged or Dislocated; Fitting Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE BUR WOULD NOT FIT THE ATTACHMENT, IT FELL OUT. 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 15257764 ↗
• MalfunctionMay 24, 2021Vibration; Vibration

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR WAS CHATTERING. 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 11869955 ↗
• MalfunctionApr 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING THE BUR BROKE IN THE ATTACHMENT. 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 Patient Involvement

  MAUDE report 10000853 ↗
• MalfunctionOct 24, 2018Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING A POSTERIOR SPINAL FUSION REVISION SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001717 ↗