FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1020987
·
Received March 28, 2008
Report
- Report Number
- 1030489-2008-00159
- Event Type
- Injury
- Date Received
- March 28, 2008
- Report Date
- February 27, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- K042025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECTED DEVICES IN USE ARE PART # G86746545, LOT # W07C2388; G86747540, LOT# W07J0402 AND G86747545, LOT W07L4387. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT, WHO HAD OSTEOPOROSIS UNDERWENT A SPINAL PROCEDURE FOR BURST FRACTURE AT T12-L4. ONE OF THE FIXATION SCREWS AT L4 BACKED OUT POST OP. A REVISION SURGERY WAS PERFORMED TO REPLACE THE SCREW, APPROX 2.5 WEEKS POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | BONE SCREW | KWP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |