FDA Adverse Event Summary report: N

BRASSELER USA SURGICAL BUR

MDR report key: 8949904 · Received August 29, 2019

Report

Report Number
MW5089475
Date Received
August 29, 2019
Report Date
August 28, 2019
Manufacturer
BRASSELER USA MEDICAL, LLC
Product Code
GFF
Report Source
Voluntary report
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

PHYSICIAN PERFORMING A MANDIBULAR OSTEOTOMY AND DURING THE PROCEDURE, A BURR BROKE. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
741920 BRASSELER USA SURGICAL BUR BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF BRASSELER USA MEDICAL, LLC 04-C0302

Patients

Seq Age Sex Outcome Treatment
1