FDA Adverse Event
Other
Summary report: N
PONTO IMPLANT WITH ABUTMENT
MDR report key: 3853788
·
Received May 28, 2014
Report
- Report Number
- 3007367732-2014-00019
- Event Type
- Other
- Date Received
- May 28, 2014
- Report Date
- May 5, 2014
- Manufacturer
- OTICON MEDICAL AB
- Product Code
- MAH
- PMA / PMN Number
- K121228
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED ON INITIAL INFO (B)(4) 2014, THE COMPLAINT WAS NOT CONSIDERED MDR REPORTABLE. UPON RECEIPT OF ADD'L INFO (B)(4) 2014 THE MDR DECISION WAS REVISED. 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 MANUFACTURING OR COMPONENT FAILURE.
Description of Event or Problem · 1
IMPLANT FELL OFF AFTER 3 MONTHS OF DEVICE USE. THERE WAS NO TRAUMA. PATIENT HAD REVISION SURGERY FOR IMPLANT AND ABUTMENT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314868 | PONTO IMPLANT WITH ABUTMENT | BONE ANCHORED HEARING IMPLANT | MAH | OTICON MEDICAL AB | M51137 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |