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

Model Number	186323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Skin and surgical wound degradation are known complications associated with the use of active transcutaneous hearing implant.Based on the available information and our trending we have no indication that the reported issue is the result of a manufacturing or quality deviation, but rather due to impaired wound healing resulting from heavy smoking.We see no increase in severity and/or occurrence of the reported issue 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.
Event or Problem Description
Skin/surgical wound necrosis at sentio implant insertion site.No indication of product malfunction.

• 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: 21899981
• Report Number: 3007367732-2025-00020
• Device Sequence Number: 14474312
• Product Code: PFO
• UDI-Device Identifier: 05712149026906
• UDI-Public: (01)05712149026906(10)24-000198(11)240122(17)270121(240)186323
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K240614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/24/2025

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: 186323
• Device Catalogue Number: 186323
• Device Lot Number: 23-02117
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown