Vitoss BBTrauma 2102-2205Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00808232001334), received between Sep 21, 2016 and Dec 13, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 13, 2017Loose or Intermittent Connection; Human Factors Issue; Human Factors Issue

  IT WAS REPORTED THAT; AS REPORTED BY REP: SURGEON NOTIFIED VIA SMS THAT POST IMPLANT FOR A PROCEDURE, FOOT BECAME SWOLLEN. UPON RE-OPENING THE WOUND, SURGEON REPORTED THAT THE PRODUCT "LOOKS LIKE IT PUFFED UP AFTER PULSE LAVAGE". A SCREW [EXACT SCREW UNKNOWN] IN THE PLATE WAS FOUND LOOSE AND EXPLANTED. REP REPORTED THAT PATIENT SUSTAINED VOCAL CHORD DAMAGE AFTER INTUBATION AND WAS ADMINISTERED PREDNAZONE. AS OF THE TIME OF REPORT, PATIENT HAD NOT GOTTEN THEIR VOICE BACK. PATIENT HAS RETAINED A LAWYER.

  Patient problems: Failure of Implant; Injury; Swelling

  MAUDE report 7112474 ↗
• MalfunctionMay 19, 2017Device Expiration Issue

  IT WAS REPORTED THAT THE HOSPITAL USED EXPIRED PRODUCT. IT WAS REPORTED THAT A PACKAGE OF EXPIRED BBT WAS USED ON A PATIENT. IT WAS REPORTED THAT THE PRODUCT HAD EXPIRY DATE: SEPTEMBER 30 2016.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6578597 ↗
• MalfunctionSep 21, 2016Device Expiration Issue; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED 5CC PRODUCT WAS USED IN A SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 5966041 ↗