FDA Adverse Event
Other
Summary report: N
BREMER 3D CROWN
MDR report key: 388530
·
Received April 11, 2002
Report
- Report Number
- 1526439-2002-00022
- Event Type
- Other
- Date Received
- April 11, 2002
- Report Date
- April 11, 2002
- Manufacturer
- DEPUY ACROMED
- Product Code
- HAX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO DEPUY ACROMED THAT A SCREW JAMMED IN THE SCREW HOLE OF A BREMER HALO. ACCORDING TO THE COMPLAINANT, THE SCREW JAMMED AND THE HALO HAD TO BE REMOVED AND REPLACED WITH ANOTHER HALO. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREMER 3D CROWN | 12" SLIDER PAIR | HAX | DEPUY ACROMED | NA | 044122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |