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

Model Number	M52169
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	03/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Activation was performed on (b)(6) 2026, and 3 days later the patient contacted the hospital due to spontaneous implant loss.
Additional Manufacturer Narrative
Implant loss is a known complication associated with the use of bone anchored hearing systems and is described in the ponto system labelling; failure of osseointegration has a variety of potential causes, including lack of adequate bone quality and/or quantity, lack of irrigation during surgery, surgical complications, infection, generalized diseases and trauma to the implant.Should the implant become loose there is normally bone available for surgical placement of a new implant close to the old site.

• 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: 25043583
• Report Number: 3007367732-2026-00027
• Device Sequence Number: 10369592
• Product Code: MAH
• UDI-Device Identifier: 05712149009619
• UDI-Public: (01)05712149009619(11)240424(17)290424(10)2417061(240)M52169
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K152067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/30/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: M52169
• Device Catalogue Number: M52169
• Device Lot Number: 2417061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• 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 Age: 53 YR
• Patient Sex: Female