FDA Adverse Event
Malfunction
Summary report: N
REFLEX HYBRID ACP
MDR report key: 1941210
·
Received December 23, 2010
Report
- Report Number
- 1941210
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- November 29, 2010
- Report Date
- December 23, 2010
- Manufacturer
- STRYKER SPINE
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
INTRAOPERATIVELY, THE SURGEON NOTED THAT THE PATIENT'S CERVICAL PLATE AND SCREW AT CERVICAL VERTEBRA 3 THROUGH 5 (C3-C5) WERE DEFECTIVE. ONE OF THE SCREWS HAD "BACKED OUT" AND THE SURGEON REMOVED THE PLATE AND SCREWS. THE PATIENT WOULD HAVE HAD TO HAVE THE PLATE AND SCREWS REMOVED ANYWAY TO PERFORM THE INTENDED SURGERY, WHICH WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION OF CERVICAL VERTEBRA 5 THROUGH THORACIC VERTEBRA 1 (C5-T1). THE PROCEDURE WAS PERFORMED AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLEX HYBRID ACP | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | KWQ | STRYKER SPINE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |