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

Model Number	186323
Medical Device Problem Codes	Failure to Align (2522); Compatibility Problem (2960)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Placing the implant incorrectly and needing to perform additional surgery poses a risk for the patient and also a risk of damaging the implant.As of submitting this report we still haven't received confirmation of when the device will explanted.As soon as we have received the device back for investigation we will amend this report with our investigation findings.Based on the currently available 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 in the reported event 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
During fitting of sound processor, it was noted the sound processor retention magnet repelled rather than attached to the implant magnet.After testing with several different magnets, the issue persisted.Revisoin surgery is planned to detmerine if the implant has been placed wrongly or if it is a device malfunction and needs to be replaced.
Event or Problem Description
During fitting of sound processor it was noted the sound processor retention magnet repelled rather than attached to the implant magnet.After testing with several differnt magnets the issue persisted.Revisoin surgery is planned to detmerine if the implant has been placed wrongly or if it is a device malfunction and needs to be replaced.
Additional Manufacturer Narrative
Placing the implant incorrectly and needing to perform additional surgery poses additional risk for the patient.The explanted device was found to be fully functional and we have concluded that the surgeon deviated from the surgical instructions and placed the device upside down.We have informed the clinci accordingly.We see no increase in severity and/or occurrence in the reported event 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: 23094342
• Report Number: 3007367732-2025-00045
• Device Sequence Number: 12933003
• Product Code: PFO
• UDI-Device Identifier: 05712149026906
• UDI-Public: (01)05712149026906(10)24-00664(11)240408(17)270408(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
• 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,Followup
• Report Date (Section B): 01/13/2026

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
• Device Model Number: 186323
• Device Catalogue Number: 186323
• Device Lot Number: 24-00664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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 Sex: Unknown