FDA Adverse Event
Injury
Summary report: N
SPINE SYSTEM 5 PEDICLE SCREW
MDR report key: 49851
·
Received November 15, 1996
Report
- Report Number
- 2916714-1996-00007
- Event Type
- Injury
- Date Received
- November 15, 1996
- Date of Event
- November 8, 1996
- Report Date
- November 15, 1996
- Manufacturer
- AESCULAP JBS, SA
- Product Code
- MCV
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FEMALE PT WAS IMPLANTED WITH SPINE SYSTEM PRODUCT AT L2-L4 LEVELS ON 7/5/96. RECENTLY COMPLAINED OF PAIN. RETURNED FOR FOLLOW-UP VISIT ON 11/6/96 DURING WHICH X-RAY WAS TAKEN AND SHOWED BROKEN SCREW AT L4 LEVEL. REOPERATION PERFORMED FOR REMOVAL AND REPLACEMENT OF BROKEN SCREW ON 11/8/96. NO COMPLICATIONS REPORTED. PHYSICIAN UNABLE TO DETERMINE CAUSE OF SCREW FRACTURE; BELIEVES PLACEMENT/IMPLANTATION OF DEVICES WAS SATISFACTORY. MALFUNCTION IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINE SYSTEM 5 PEDICLE SCREW Implant | PEDICLE SCREW | MCV | AESCULAP JBS, SA | NA | LT91JG1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other| R |