FDA Adverse Event
Other
Summary report: N
PONTO IMPLANT 4MM WITH ABUTMENT 6MM
MDR report key: 1993450
·
Received February 10, 2011
Report
- Report Number
- 3007367732-2011-00002
- Event Type
- Other
- Date Received
- February 10, 2011
- Date of Event
- November 20, 2010
- Report Date
- January 30, 2011
- Manufacturer
- OTICON MEDICAL AB
- Product Code
- LXB
- PMA / PMN Number
- K090996
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE IMPLANT IS TO BE RETURNED TO OTICON MEDICAL AFTER STERILIZATION. THERE ARE NO INDICATION THAT THE OCCURRED IS A RESULT OF MANUFACTURING OR COMPONENT FAILURE. THE EVENT IS KNOWN TO OCCUR, BASED ON KNOWN FACTS FOR (B)(4) IMPLANTS INTENDED FOR OSSEOINTEGRATION.
Description of Event or Problem · 1
ADULT PATIENT WITH NO KNOWN HEALTH CONDITIONS (OTHER THAN HEARING LOSS). SURGERY WAS UNEVENTFUL. PATIENT WAS SEEN FOR FOLLOW-UP AND FITTING OF EXTERNAL SOUND PROCESSOR WHEN IT WAS OBSERVED THAT THE IMPLANT HAD EXTRUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PONTO IMPLANT 4MM WITH ABUTMENT 6MM | LXB - HEARING AID, BONE CONDUCTION | LXB | OTICON MEDICAL AB | M50358 | 102319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |