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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALTATEC ALTATEC; DENTAL IMPLANT
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ALTATEC ALTATEC; DENTAL IMPLANT Back to Search Results
Model Number K1055.4311
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/03/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.
 
Event or Problem Description
Implant removed due to surgical consideration within 36 hours.
 
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Brand Name
ALTATEC
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
ALTATEC
maybachstrasse 5
wimsheim 71299
GM  71299
MDR Report Key19269233
Report Number1060818-2024-60315
Device Sequence Number15299620
Product Code DZE
UDI-Device IdentifierE219K105543111
UDI-PublicE219K105543111
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 05/20/2024
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 NumberK1055.4311
Device Catalogue NumberK1055.4311
Device Lot Number0020136134
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date04/03/2024
Type of Report(Section G)Follow-Up
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date05/08/2024
Supplement Report FDA Received Date05/20/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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