FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 302485
·
Received October 28, 2000
Report
- Report Number
- 302485
- Event Type
- Injury
- Date Received
- October 28, 2000
- Date of Event
- September 1, 2000
- Report Date
- October 26, 2000
- Manufacturer
- UNK
- Product Code
- JAZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT REPORTED JAW IMPLANT PLACED BY "UNKNOWN" DENTIST APPROX 10 YEARS AGO. CAUSATIVE FOR OSTEOMYELITIS TYPE INFECTION OF THE LEFT MANDIBLE WARRANTING IMPLANT REMOVAL WITH BONE GRAFT REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | MANDIBLE IMPLANT | JAZ | UNK | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |