FDA Adverse Event
Injury
Summary report: N
REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM
MDR report key: 1030116
·
Received April 14, 2008
Report
- Report Number
- 9617544-2008-00032
- Event Type
- Injury
- Date Received
- April 14, 2008
- Date of Event
- March 31, 2008
- Report Date
- March 31, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWQ
- PMA / PMN Number
- K040261
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS UNAVAILABLE FOR EVALUATION, BUT ADD'L INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUPPLIED ON A SUPPLEMENTAL.
Description of Event or Problem · 1
THE SUBJECT HAD A C5-6 FUSION IN 2007 WITH PERSISTENT RIGHT ARM AND SHOULDER PAIN 1 MONTH AFTER SURGERY. A CT SCAN WAS ORDERED RECENTLY, WHICH SHOWED INCOMPLETE FUSION INFERIORLY AT THE C5-6 INTERSPACE. SUPPLEMENTAL POSTERIOR FIXATION WAS ADDED DURING REVISION SURGERY IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM | IMPLANT | KWQ | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |