FDA Adverse Event
Injury
Summary report: N
SPINE SYSTEM IMPLANTS
MDR report key: 80868
·
Received March 25, 1997
Report
- Report Number
- 2916714-1997-00005
- Event Type
- Injury
- Date Received
- March 25, 1997
- Report Date
- March 25, 1997
- Manufacturer
- AESCULAP/JBS SA
- Product Code
- KWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PHYSICIAN DID NOT RESPOND TO REQUESTS FOR ADD'L INFO. UNABLE TO CONFIRM DETAILS OF THIS EVENT. INVESTIGATION IS NOW CONSIDERED CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINE SYSTEM IMPLANTS Implant | PEDICLE SCREW | KWP | AESCULAP/JBS SA | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |