Sentio 186323Recalls & reported problems
Oticon Medical AB · SENTIO TI IMPLANT KIT · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05712149026906), received between Feb 7, 2025 and Sep 19, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Compatibility Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Compatibility Problem1
- Failure to Align1
Patient problems
- Wound Dehiscence3
- Post Operative Wound Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Necrosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2025Failure to Align; Compatibility Problem; Failure to Align; Compatibility Problem
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.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23094342 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SKIN/SURGICAL WOUND BREAKDOWN AT SENTIO IMPLANT INSERTION SITE. NO INDICATION OF PRODUCT MALFUNCTION. HOSPITALIZATION FOR EXPLANTING THE MEDICAL DEVICE.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 21899982 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SKIN/SURGICAL WOUND NECROSIS AT SENTIO IMPLANT INSERTION SITE. NO INDICATION OF PRODUCT MALFUNCTION.
Patient problems: Necrosis; Wound Dehiscence
MAUDE report 21899981 ↗InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SKIN/SURGICAL WOUND BREAKDOWN AT SENTIO IMPLANT SITE. NO INDICATION OF PRODUCT MALFUNCTION. HOSPITALIZATION FOR EXPLANTING THE MEDICAL DEVICE. NO SERIOUS OUTCOME.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 21330993 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.