FDA Adverse Event
Injury
Summary report: N
ARTELON CMC SPACER
MDR report key: 2893949
·
Received December 19, 2012
Report
- Report Number
- 3004878714-2012-00013
- Event Type
- Injury
- Date Received
- December 19, 2012
- Date of Event
- March 8, 2012
- Report Date
- December 14, 2012
- Manufacturer
- ARTIMPLANT AB
- Product Code
- KYI
- PMA / PMN Number
- K040070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION BASED ON LAWSUIT DOCUMENTS FILED AGAINST ARTIMPLANT (B)(4) AND ARTIMPLANT USA, INC. NO INFORMATION SUPPORTING ALLEGATIONS OF LAWSUIT CURRENTLY AVAILABLE.
Description of Event or Problem · 1
AN ARTELON CMC SPACER WAS EXPLANTED ON (B)(6) 2012 DUE TO ALLEGED INJURY. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTELON CMC SPACER | SPACER | KYI | ARTIMPLANT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Disability |