FDA Adverse Event
Injury
Summary report: N
CD HORIZON AGILE SPINAL SYSTEM
MDR report key: 1051063
·
Received May 22, 2008
Report
- Report Number
- 1030489-2008-00238
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 4, 2008
- Report Date
- April 24, 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
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS A FOLLOW UP FOR USER FACILITY REPORT NUMBER 150034-2008-0002. THE HOSP HAS NOT RETURNED THE DEVICE TO MEDTRONIC FOR EVAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT L3-5 LAMINECTOMY AND TLIF WITH POSTERIOR DYNAMIC ROD FIXATION AND HA COATED SCREWS AT L3-5. IT WAS REPORTED THAT THE PT UNDERWENT AN ADDITIONAL SURGERY APPROX 7 MONTHS POST-OP, DUE TO "DEFECTIVE HARDWARE" TO REMOVE THE CONSTRUCT.
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 | 43 YR | Required Intervention |