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

Model Number	M51137
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Skin Infection (4544)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
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; spontaneous implant loss 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.
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 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: 17511621
• Report Number: 3007367732-2023-00035
• Device Sequence Number: 20198687
• Product Code: MAH
• UDI-Device Identifier: 05712149003921
• UDI-Public: 0105712149003921111706291722062910172653
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 08/11/2023

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: 06/29/2022
• Device Model Number: M51137
• Device Catalogue Number: M51137
• Device Lot Number: 172653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2017
• 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