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

Model Number	M50349
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Infections, pain and abutment skin overgrowth are 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
Skin irritation/infection - abutment 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: 18237059
• Report Number: 3007367732-2023-00054
• Device Sequence Number: 20623085
• Product Code: MAH
• UDI-Device Identifier: 05712149000470
• UDI-Public: 0105712149000470112006051725060510202392240M50349
• Combination Product (Y/N): N
• 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): 11/30/2023

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: 06/05/2025
• Device Model Number: M50349
• Device Catalogue Number: M50349
• Device Lot Number: 202391
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2020
• 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: 9 YR
• Patient Sex: Male