FDA Adverse Event
Other
Summary report: N
PONTO IMPLANT WITH ABUTMENT
MDR report key: 2930953
·
Received January 10, 2013
Report
- Report Number
- 3007367732-2013-00002
- Event Type
- Other
- Date Received
- January 10, 2013
- Date of Event
- December 31, 2012
- Report Date
- January 10, 2013
- Manufacturer
- OTICON MEDICAL AB
- Product Code
- LXB
- PMA / PMN Number
- K082108
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IMPLANT LOSS IS KNOWN TO OCCUR, CONSIDERED IN THE RMF AND COMMUNICATED IN THE PT INFO. THERE ARE NO INDICATIONS THAT THE OCCURRED IS A RESULT OF MFG OR COMPONENT FAILURE.
Description of Event or Problem · 1
PT REPORTED TO PARENT THAT IS ABUTMENT WAS LOOSE APPROX ONE WEEK BEFORE IT FELL OUT WHILE SHOWERING ((B)(6) 2012). PT DENIES ANY TRAUMA TO HEAD OR TO IMPLANT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16014 | PONTO IMPLANT WITH ABUTMENT | BONE ANCHORED HEARING IMPLANT | LXB | OTICON MEDICAL AB | M50785 | 114818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |