FDA Adverse Event
Injury
Summary report: N
ZERO PROFILE TWO-LEVEL ACP SIZE 32MM
MDR report key: 2081363
·
Received April 29, 2011
Report
- Report Number
- 9617544-2011-00149
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- July 3, 2008
- Report Date
- April 1, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K063430
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "IT IS ALLEGED THAT ON (B)(6) 2008, THE PT UNDERWENT A TWO LEVEL ANTERIOR CERVICAL DECOMPRESSION AND FUSION. SIX MONTHS LATER IN (B)(6) 2009, THE PT WAS REVISED DUE TO AN ALLEGED "NO SOLID FUSION". THE PT ALSO ALLEGES CENTRAL CORD DAMAGE WHICH HAS RESULTED IN PAIN, LEG WEAKNESS AND INCONTINENCE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZERO PROFILE TWO-LEVEL ACP SIZE 32MM | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |