FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON AGILE SPINAL SYSTEM
MDR report key: 1083694
·
Received July 24, 2008
Report
- Report Number
- 1030489-2008-00367
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Report Date
- June 27, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- NQP
- PMA / PMN Number
- K060615
- Removal / Correction Number
- 1030489-122107-009-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS REPORTED TO REMAIN IMPLANTED; THEREFORE NO PRODUCT IS AVAILABLE FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT SOMETIME POST-OP, X-RAYS REVEALED THE PT HAS A BROKEN DYNAMIC POSTERIOR ROD. THE PT IS REPORTED TO BE ASYMPTOMATIC AND NO REVISION IS CURRENTLY PLANNED. THE SURGEON WILL MONITOR THE PT EVERY 3 MONTHS. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON AGILE SPINAL SYSTEM | NQP | WARSAW ORTHOPEDIC INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |