FDA Adverse Event
Injury
Summary report: N
CD HORIZON AGILE SPINAL SYSTEM
MDR report key: 1152835
·
Received September 4, 2008
Report
- Report Number
- 1030489-2008-00492
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 5, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- NQP
- PMA / PMN Number
- K060615
- Removal / Correction Number
- 1030489-122107-009-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BOTH RODS WERE RETURNED TO MEDTRONIC FOR EVAL. VISUAL EXAMINATION CONFIRMED EACH ROD HAS FRACTURED CABLE FIBERS OCCURRING AT EACH ROD 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 THE PT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE POSTERIOR CONSTRUCT WITH TWO BROKEN RODS. 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 | AT2007020440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |