N/A 2900161CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994121028), received between Aug 21, 2017 and Aug 21, 2017 — classified as 1 injury.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2017Break; Break

  PRE-OP DIAGNOSIS: DYSPLASTIC ANTEROSPONDOLYTHESIS LEVELS OPERATED: L5-S1 IT WAS REPORTED THAT DURING SURGERY, THE RASP GAVE AWAY AND THE HEAD OF THE RASP WENT MISSING INSIDE THE DISC SPACE. THE FRAGMENT OF THE RASP COULD NOT BE RETRIEVED AND HENCE REMAINED IN THE PATIENT. THE SURGICAL TIME WAS INCREASED TRYING TO RETRIEVE THE BROKEN INSTRUMENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6806749 ↗