FDA Adverse Event
Injury
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2173586
·
Received July 23, 2011
Report
- Report Number
- 1030489-2011-00922
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- July 1, 2009
- Report Date
- June 24, 2011
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- NQP
- PMA / PMN Number
- K060615
- Removal / Correction Number
- 1030489-122107-009R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 2 YEARS POST-OP FOR UNKNOWN REASONS. DURING THE REVISION SURGERY, IT WAS FOUND THAT THE RODS WERE BROKEN. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION | NQP | WARSAW ORTHOPEDIC, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCREWS |