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

Model Number	186332
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Skin/surgical wound breakdown at sentio implant site.No indication of product malfunction.Hospitalization for explanting the medical device.No serious outcome.
Additional Manufacturer Narrative
Skin and surgical wound degradation are known complications associated with the use of active transcutaneous hearing implant.Likely the patient's cancer treatments was a contributing factor in causing this issue.Based on the avilable information and our trending we have no indication that the reported issue is the result of a manufacturing or quality deviation.We see no increase in severity and/or occurrence that would necessitate updating the risk assessment or to perform actions other than continued trending.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.

• Brand Name: SENTIO TI IMPLANT
• 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: 21330993
• Report Number: 3007367732-2025-00003
• Device Sequence Number: 8697239
• Product Code: PFO
• UDI-Device Identifier: 05712149026906
• UDI-Public: (01)05712149026906(10)23-02117(11)231017(17)231016(240)186332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K240614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 02/07/2025

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: 186332
• Device Catalogue Number: 186332
• Device Lot Number: 23-02117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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: 55 YR
• Patient Sex: Female