FDA Adverse Event
Malfunction
Summary report: N
BURR, ORTHOPEDIC
MDR report key: 17529484
·
Received August 12, 2023
Report
- Report Number
- MW5136410
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- November 10, 2016
- Manufacturer
- UNKNOWN
- Product Code
- HTT
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT, A BROKEN BUR WAS OBSERVED INSIDE THE ATTACHMENT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. 0001811755-2016-02805. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763192 | BURR, ORTHOPEDIC | BURR, ORTHOPEDIC | HTT | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |