EXACT REVERSE FP FULL TOOTH RASP SSI005610Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024584877), received between Mar 20, 2020 and Mar 20, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT PATIENT RASP INSTRUMENTS WERE FOUND TO HAVE FRACTURED ON THE MEDIAL SIDE. IT IS UNKNOWN HOW AND/OR WHEN THE FRACTURES OCCURRED AND NO KNOWN HARM OR INJURY TO A PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9860006 ↗
• MalfunctionMar 20, 2020Fracture; Fracture

  UPON REVIEW OF ADDITIONAL INFORMATION RECEIVED, IT WAS FOUND THAT ONLY ONE SET OF RASPS WERE FRACTURED THEREFORE THIS DEVICE IS CONSIDERED NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9860002 ↗
• MalfunctionMar 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT PATIENT RASP INSTRUMENTS WERE FOUND TO HAVE FRACTURED ON THE MEDIAL SIDE. IT IS UNKNOWN HOW AND/OR WHEN THE FRACTURES OCCURRED AND NO KNOWN HARM OR INJURY TO A PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9859996 ↗