FDA Adverse Event
Malfunction
Summary report: N
TRIDENT TRAY
MDR report key: 16132245
·
Received January 9, 2023
Report
- Report Number
- MW5114246
- Event Type
- Malfunction
- Date Received
- January 9, 2023
- Manufacturer
- ADVANCED RESEARCH MEDICAL LLC.
- Product Code
- OUR
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AMW SCREWDRIVER TIP BROKE OFF IN PT WHILE USING IT. DR (B)(6) WAS ABLE TO REMOVE ALL PIECES AND PARTS FROM PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1680919 | TRIDENT TRAY | SACROILIAC JOINT FIXATION | OUR | ADVANCED RESEARCH MEDICAL LLC. | 03-05 REV A | AC237AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |