FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3190327
·
Received June 26, 2013
Report
- Report Number
- 1030489-2013-02523
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 28, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
- Product Code
- KWP
- PMA / PMN Number
- K981676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (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 HE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SETSCREW SLIPPED DURING INSERTION INTO THE BONE SCREW. THE SETSCREW WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290781 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS | NA | H13B014X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |