FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON AGILE SPINAL SYSTEM
MDR report key: 1122785
·
Received July 31, 2008
Report
- Report Number
- 1030489-2008-00410
- Event Type
- Malfunction
- Date Received
- July 31, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 1, 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVAL. VISUAL EXAMINATION CONFIRMED THAT ONE ROD HAD A FRACTURED CABLE WITH FAILURES OCCURRING AT EACH FLANGE. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY TO REMOVE THE POSTERIOR CONSTRUCT, THE SURGEON NOTICED THAT ONE OF THE DYNAMIC RODS WAS BROKEN ON THE RIGHT SIDE OF THE CONSTRUCT. THE IMPLANTS WERE REMOVED WITHOUT ANY COMPLICATIONS. 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 | AT200610P025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |