FDA Adverse Event
Other
Summary report: N
MOSS MIAMI SPINAL SYSTEM
MDR report key: 394957
·
Received May 15, 2002
Report
- Report Number
- 1526439-2002-00031
- Event Type
- Other
- Date Received
- May 15, 2002
- Date of Event
- December 17, 1999
- Report Date
- May 15, 2002
- Manufacturer
- DEPUY ACROMED, INC.
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO DEPUY ACROMED VIA GENERAL COUNSEL THAT A PT WAS IMPLANTED WITH MOSS MIAMI HARDWARE IN 1998. ACCORDING TO THE COMPLAINT, IT WAS DISCOVERED THAT THE HARDWARE WAS "DEFECTIVE" IN 1999 WHEN THE HARDWARE WAS REMOVED. THE PT THEN DEVELOPED AN ACUTE NARCOTIC CONDITION FROM THE PRESCRIBED PAIN MEDICATION. THE PRODUCT AND LOT CODE INFO WAS NOT AVAILABLE. THE IMPLANTS WERE NOT RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOSS MIAMI SPINAL SYSTEM | UNK | KWQ | DEPUY ACROMED, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |