FDA Adverse Event
Other
Summary report: N
PONTO IMPLANT WITH ABUTMENT
MDR report key: 3011161
·
Received March 12, 2013
Report
- Report Number
- 3007367732-2013-00006
- Event Type
- Other
- Date Received
- March 12, 2013
- Date of Event
- February 7, 2013
- Report Date
- March 12, 2013
- Manufacturer
- OTICON MEDICAL AB
- Product Code
- LXB
- PMA / PMN Number
- K121228
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT HAD SURGERY ON (B)(6) 2012. IT WAS OBSERVED THAT PT HAD "HONEYCOMB CORTICL BONE" RESULTING IN SPINNER IMPLANTS. PT ALSO IMPLANTED WITH A SECONDARY IMPLANT IN THE EVENT THE PRIMARY IMPLANT DID NOT OSSEOINTEGRATE. PT FIT ABUTMENT ON (B)(6) 2012 AND FIT WITH EXTERNAL PROCESSOR ON (B)(6) 2012. ON (B)(6) 2013 PT FOUND THE IMPLANT/ABUTMENT ON HIS PILLOW. PT NOT TO BE RE-IMPLANTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104978 | PONTO IMPLANT WITH ABUTMENT | BONE ANCHORED HEARING IMPLANT | LXB | OTICON MEDICAL AB | M50358 | 105016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |