FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 1070064
·
Received July 3, 2008
Report
- Report Number
- 1030489-2008-00313
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 31, 2008
- Report Date
- June 5, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- KWP
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, PRODUCT HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT RETURNED TO THE HOSPITAL EXPERIENCING PAIN. X-RAYS TAKEN IN 2008 REVEALED THE ILIAC SCREW ON THE RIGHT SIDE OF THE CONSTRUCT HAD DISASSEMBLED. THE HEAD HAD SEPARATED FROM THE POST. NO REVISION SURGERY HAS TAKEN PLACE. NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | ILIAC SCREW | KWP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |