FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON AGILE SPINAL SYSTEM
MDR report key: 1348774
·
Received February 5, 2009
Report
- Report Number
- 1030489-2009-00099
- Event Type
- Malfunction
- Date Received
- February 5, 2009
- Date of Event
- May 22, 2008
- Report Date
- January 6, 2009
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- NQP
- PMA / PMN Number
- K060615
- Removal / Correction Number
- 1030489-122107-009R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO MEDTRONIC FOR EVALUATION. IT WAS REPORTED THAT THE IMPLANTS WERE DISCARDED AT THE HOSPITAL FOLLOWING REMOVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR TLIF AT L4-5 AND L5-S1 AND POSTERIOR FIXATION AT L2-S1 WITH DYNAMIC SEGMENT AT L2-3. FOLLOW-UP VISIT IN 2008 CONFIRMED HEALED L3 TO SACRUM FUSION WITH HARDWARE INTACT. APPROXIMATELY 1 MONTH LATER, THE PATIENT UNDERWENT HARDWARE REMOVAL WHERE IT WAS FOUND THAT THE RIGHT SIDED ROD CABLE HAD FRACTURED. NO PATIENT 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 | 44 YR | Required Intervention |