FDA Adverse Event
Injury
Summary report: N
ARTELON CMC SPACER
MDR report key: 1972209
·
Received January 18, 2011
Report
- Report Number
- 3004878714-2011-00002
- Event Type
- Injury
- Date Received
- January 18, 2011
- Report Date
- January 17, 2011
- Manufacturer
- ARTIMPLANT AB
- Product Code
- KYI
- PMA / PMN Number
- K040070
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AT THIS POINT, VERY LITTLE INFO IS AVAILABLE BUT SOME KIND OF USER ERROR IS SUSPECTED. AT MEETING WITH THE SURGEONS IN (B)(4) LAST WEEK, IT WAS ONLY CONCLUDED THAT MORE INFO ABOUT THE PTS AND THE SURGERY WAS REQUIRED AND THE DISCUSSION WILL CONTINUE.
Description of Event or Problem · 1
REOPERATION OF 10 OUT OF 19 IMPLANTED SPACERS BY THREE DIFFERENT SURGEONS. ONE OF THEM WHO IS TRAINED BY AN EXPERIENCED SURGEON, HAS TRAINED THE OTHERS. (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 | Other |