FDA Adverse Event
Injury
Summary report: N
ARTELON CMC SPACER
MDR report key: 1298769
·
Received January 30, 2009
Report
- Report Number
- 3004878714-2009-00002
- Event Type
- Injury
- Date Received
- January 30, 2009
- Date of Event
- December 8, 2008
- Report Date
- January 14, 2009
- Manufacturer
- ARTIMPLANT
- Product Code
- KYI
- PMA / PMN Number
- K040070
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOT DOCUMENTATION REVIEWED. HISTOLOGICAL EXAMINATION SHOWED NO SIGN OF INFECTION OR INFLAMMATION. CONCLUSION IS THAT THE EXPLANT WAS NOT CAUSED BY THE PRODUCT.
Description of Event or Problem · 1
EXPLANTATION DUE TO INFLAMMATION 5 MONTHS AFTER IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTELON CMC SPACER | SPACER | KYI | ARTIMPLANT | 21109 | 0702002720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |