FDA Adverse Event
Other
Summary report: N
PONTO IMPLANT WITH ABUTMENT
MDR report key: 4321083
·
Received November 28, 2014
Report
- Report Number
- 3007367732-2014-00048
- Event Type
- Other
- Date Received
- November 28, 2014
- Date of Event
- October 13, 2014
- Report Date
- November 5, 2014
- Manufacturer
- OTICON MEDICAL AB
- Product Code
- MAH
- PMA / PMN Number
- K121228
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IMPLANT LOSS IS KNOWN TO OCCUR, CONSIDERED IN THE RMF AND COMMUNICATED IN THE IFU. THERE ARE NO INDICATIONS THAT THE OCCURRED IS A RESULT OF MRG OR COMPONENT FAILURE.
Description of Event or Problem · 1
IMPLANT LOSS. PT WILL HAVE REVISION SURGERY, DATE NOT YET DECIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771652 | PONTO IMPLANT WITH ABUTMENT | BONE ANCHORED HEARING IMPLANT | MAH | OTICON MEDICAL AB | M51136 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |