FDA Adverse Event
Malfunction
Summary report: N
BREMMER HALO
MDR report key: 532990
·
Received July 2, 2004
Report
- Report Number
- 532990
- Event Type
- Malfunction
- Date Received
- July 2, 2004
- Date of Event
- June 12, 2004
- Report Date
- June 22, 2004
- Manufacturer
- DEPUY ACROMED
- Product Code
- KQZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ND, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING HALO PLACEMENT TWO OF THE FOUR PINS BECAME LODGED AND VERY DIFFICULT TO REMOVE FROM THE RINGS. AFTER REMOVAL, UPON INSPECTION IT WAS VISIBLE THAT THE PIN THREADS AND RINGS HAD COLD WELDED. TWO NEW PINS PLACED WITHOUT INCIDENT.
Description of Event or Problem · 1
ADD'L INFO REC'D FORM MFR 9/30/04: PREVIOUS SUBMITTED REPORT: NOT REPORTED.
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 9/9/04: MFR IS CURRENTLY IN THE PROCESS OF GATHERING THE INFO REQUIRED AND WILL RESPOND AS SOON AS THE INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREMMER HALO | HALO | KQZ | DEPUY ACROMED | * | 46986 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |