FDA Adverse Event
Injury
Summary report: N
ARTELON CMC SPACER
MDR report key: 3001627
·
Received March 6, 2013
Report
- Report Number
- 3004878714-2013-00004
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- May 14, 2012
- Report Date
- March 1, 2013
- Manufacturer
- ARTIMPLANT AB
- Product Code
- KYI
- PMA / PMN Number
- K040070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION BASED ON LAWSUIT DOCUMENTS FILED AGAINST ARTIMPLANT AB AND ARTIMPLANT US, INC. NO INFORMATION SUPPORTING THE 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 |
|---|---|---|---|---|---|---|---|
| 95822 | ARTELON CMC SPACER | SPACER | KYI | ARTIMPLANT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Disability |