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

Model Number	M51137
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant loss - spontanieous loss.
Event or Problem Description
Implant loss-spontaneous loss.

• Brand Name: PONTO
• Common Device Name: BONE ANCHORED HEARING IMPLANT
• Manufacturer (Section D): OTICON MEDICAL AB; datavägen 37 b; askim, 43632 ; SW 43632
• Manufacturer (Section G): OTICON MEDICAL AB; datavägen 37 b; askim, 43632 ; SW 43632
• Manufacturer Contact: karl almén burman ; datavägen 37b; askim, 436 3-2 ; SW 436 32
• MDR Report Key: 15734583
• Report Number: 3007367732-2022-00042
• Device Sequence Number: 2918156
• Product Code: MAH
• UDI-Device Identifier: 05712149003921
• UDI-Public: 0105712149003921111803131723031310181127240M51137
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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: 03/13/2023
• Device Model Number: M51137
• Device Catalogue Number: M51137
• Device Lot Number: 181127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male