FDA Adverse Event
Malfunction
Summary report: N
PE INLAY
MDR report key: 2031755
·
Received February 25, 2011
Report
- Report Number
- 2520274-2011-00034
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Report Date
- February 3, 2011
- Manufacturer
- SYNTHES (USA)
- Product Code
- KWY
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS UNABLE TO PROVIDE THE PMA/510K NUMBER, EXPIRATION DATE AND THE DATE OF MANUFACTURE AT THIS TIME. IT WILL BE DETERMINED IN THE DEVICE HISTORY RECORDS REVIEW: DHR REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
PATIENT PARTICIPATED IN A MULTI-LEVEL PRODISC-L FOUR (4) YEAR STUDY PROGRAM, IMPLANTATION, LEVELS L4-L5 AND L5-S1, AND RECEIVED SURGERY ON (B)(6) 2004 AT (B)(6) HOSPITAL IN (B)(6). ON A FOLLOW UP VISIT, DATE UNKNOWN, PATIENT PRESENTED WITH CONTINUED PAIN. PATIENT WAS ADVISED TO CONTINUE PAIN MANAGEMENT. NO ADDITIONAL MEDICAL TREATMENT WAS PROVIDED. THIS IS THREE OF SIX REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PE INLAY | PE INLAY | KWY | SYNTHES (USA) | NA | 51175849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SUPERIOR PLATE| INFERIOR PLATE |