FDA Adverse Event
Malfunction
Summary report: N
RADIONICS NON-DISPOSABLE HEAD RING SCREWS (LONG)
MDR report key: 609861
·
Received July 8, 2004
Report
- Report Number
- 1222895-2004-00004
- Event Type
- Malfunction
- Date Received
- July 8, 2004
- Report Date
- June 9, 2004
- Manufacturer
- RADIONICS
- Product Code
- HBL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE USER WAS AFFIXING THE BRW HEAD RING TO THE PT'S HEAD AND THE HEAD RING SCREW BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIONICS NON-DISPOSABLE HEAD RING SCREWS (LONG) | NON-DISPOSABLE HEAD RING SCREWS (LONG) | HBL | RADIONICS | HRS (L) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |