FDA Adverse Event
Malfunction
Summary report: N
CD HORIZON SPINAL SYSTEM
MDR report key: 3782073
·
Received April 30, 2014
Report
- Report Number
- 1030489-2014-02377
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- April 4, 2014
- Report Date
- April 4, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- KWP
- PMA / PMN Number
- K051674
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 MINIMALLY INVASIVE SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT DURING ROD INSERTION THE ROD CAME OFF OF THE ROD INSERTER. THE SURGEON WAS ABLE TO RETRIEVE THE ROD THROUGH THE SAME PATH. IT WAS NOTICED AFTER THE CASE THAT THE LEVER THAT HOLDS THE ROD HAD POPPED UP ALLOWING THE ROD TO RELEASE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260932 | CD HORIZON SPINAL SYSTEM | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | KWP | MEDTRONIC SOFAMOR DANEK USA, INC | NA | SA10K032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ROD |