MAUDE Adverse Event Report: Oticon Medical AB Ponto; Bone anchored hearing implant

Model Number	M52169
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant loss-spontaneous 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.According to our statistics there is not a trend in these types of events related to our products.

• 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: 50814995
• Report Number: 3007367732-2026-00057
• Device Sequence Number: 21387040
• Product Code: MAH
• UDI-Device Identifier: 05712149009619
• UDI-Public: (01)05712149009619(11)250331(17)300331(10)2514006(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
• 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): 09/18/2026

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: 2514006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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