FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 2132778
·
Received June 17, 2011
Report
- Report Number
- 1030489-2011-00761
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- KWP
- PMA / PMN Number
- K061591
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
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 LUMBAR SPINAL FUSION AT L3-S1. IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS AFTER SURGERY, THE S1 SCREW BROKE IN HALF. REPORTEDLY, THE PATIENT HAD NO TRAUMA-NO FALL, ETC. NO REVISION SURGERY IS SCHEDULED AT THIS TIME. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00048 YR | ROD |