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

Model Number	M52171
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant loss due to loss of osseointegration is a known complication associated with percutaneous implant systems, 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, but an event more likley attributed to the radiation theraphy affecting the bone density/quality.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.
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 37b; askim, 43632 ; SW 43632
• Manufacturer (Section G): OTICON MEDICAL AB; datavägen 37b; askim, 43632 ; SW 43632
• Manufacturer Contact: karl almen burman ; datavägen 37b; askim, 43632 ; SW 43632
• MDR Report Key: 24895938
• Report Number: 3007367732-2026-00025
• Device Sequence Number: 9727311
• Product Code: MAH
• UDI-Device Identifier: 05712149009633
• UDI-Public: (01)05712149009633(11)240424(17)290424(10)2417062(240)M52171
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/16/2026

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
• Device Model Number: M52171
• Device Catalogue Number: M52171
• Device Lot Number: 2417062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: Other
• Patient Sex: Unknown