MAUDE Adverse Event Report: OTICON MEDICAL AB PONTO; BONE ANCHORED HEARING IMPLANT

Model Number	M52167
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/05/2016
Event or Problem Description
Implant/abutment spontaneously extruded.

• Brand Name: PONTO
• Common Device Name: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; datavägen 37b; askim, västra götaland SE-43 6 32; SW SE-436 32
• MDR Report Key: 6099061
• Report Number: 3007367732-2016-00082
• Device Sequence Number: 10836428
• Product Code: MAH
• UDI-Device Identifier: 05712149009596
• UDI-Public: 0105712149009596111509291720092910154044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2016
• Report Date (Section F): 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/29/2020
• Device Model Number: M52167
• Device Catalogue Number: M52167
• Device Lot Number: 154044
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/28/2016
• Device Age: 2 MO
• Date Report to Manufacturer: 10/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR