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

Model Number	M52170
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	02/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Skin overgrowth are known possible post-operative complications and are considered in the rmf.There are to date no indications of increased incidence of occurance with the ponto system compared to similar products on the market.Based on the available information no further actions are taken at this point.
Event or Problem Description
Removed implant due to skin overgrowth.

• 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 37 b; askim, 43632 ; SW 43632
• MDR Report Key: 18949385
• Report Number: 3007367732-2024-00019
• Device Sequence Number: 7078768
• Product Code: MAH
• UDI-Device Identifier: 05712149009626
• UDI-Public: 01057121490096261122121317271213102250021240M5
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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 Model Number: M52170
• Device Catalogue Number: M52170
• Device Lot Number: 2250021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• 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 Sex: Male