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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® CMC 1; FINGER PROSTHESIS

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KERI MEDICAL SA TOUCH® CMC 1; FINGER PROSTHESIS Back to Search Results
Model Number NTO158
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 06/23/2026
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
All information reasonably known by the importer is included in this report.
 
Event or Problem Description
It was reported a revision, roughly two weeks post op, dislocated and replaced with a larger neck.
 
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Brand Name
TOUCH® CMC 1
Common Device Name
FINGER PROSTHESIS
Manufacturer (Section D)
KERI MEDICAL SA
chemin du pre-fleuri 5
geneva, plan-les-ouates 1228
SZ  1228
MDR Report Key25734306
Report Number3009540749-2026-00006
Device Sequence Number21435623
Product Code KYJ
UDI-Device Identifier07640181160051
UDI-Public07640181160051
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/07/2026
Report Date (Section F) 07/07/2026
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
Operator of Device Health Professional
Device Model NumberNTO158
Device Lot Number9347
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/25/2026
Event Location Hospital
Date Report to Manufacturer06/29/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/07/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
Date Report Sent to FDA07/07/2026
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