FDA Adverse Event
Injury
Summary report: N
ARTELON CMC SPACER
MDR report key: 1279470
·
Received January 7, 2009
Report
- Report Number
- 3004878714-2008-00048
- Event Type
- Injury
- Date Received
- January 7, 2009
- Date of Event
- November 18, 2008
- Report Date
- December 9, 2008
- Manufacturer
- ARTIMPLANT AB
- Product Code
- KYI
- PMA / PMN Number
- K040070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPLANT SENT FOR HISTOLOGICAL EXAMINATION.
Description of Event or Problem · 1
EXPLANT DUE TO PAIN, AND SWELLING WITH REDNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTELON CMC SPACER | SPACER | KYI | ARTIMPLANT AB | 21109 | 0702002721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |