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

Model Number	M52172
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant loss is known to occur, considered in the risk management file and communicated in the ifu.There are no indications that the occurred is a result of manufacturing or component failure.These incidents do not involve serious injury and are not considered as safety issues, but they are reported due to the intervention required for the patient to be able to continue using the bone anchored hearing system.
Event or Problem Description
The patient was implanted in a two stage procedure, in (b)(6) 2017.When attaching the abutment the auditory osseointegrated implant came out.Patient was implanted with a back up implant.

• Brand Name: PONTO
• Common Device Name: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; datavagen 37b; askim, 43632 ; SW 43632
• MDR Report Key: 7002490
• Report Number: 3007367732-2017-00080
• Device Sequence Number: 444427
• Product Code: MAH
• UDI-Device Identifier: 05712149009657
• UDI-Public: 0105712149009657111606031721060310162265
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K152067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2017
• Report Date (Section F): 05/23/2017

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: 03/06/2021
• Device Model Number: M52172
• Device Catalogue Number: M52172
• Device Lot Number: 162265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2017
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 11/06/2017
• 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: 5 YR