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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRA-LOCK INTERNATIONAL, INC. INTRA-LOCK INTERNATIONAL, INC.; DENTAL IMPLANT
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INTRA-LOCK INTERNATIONAL, INC. INTRA-LOCK INTERNATIONAL, INC.; DENTAL IMPLANT Back to Search Results
Model Number S4708
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 05/14/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
 
Event or Problem Description
Implant failed to osseointegrate.
 
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Brand Name
INTRA-LOCK INTERNATIONAL, INC.
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
INTRA-LOCK INTERNATIONAL, INC.
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
INTRA-LOCK INTERNATIONAL, INC.
2300 riverchase center
birmingham AL 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham, AL 35244
MDR Report Key22174970
Report Number3003631996-2025-00399
Device Sequence Number7957867
Product Code DZE
UDI-Device IdentifierD742S47080
UDI-PublicD742S47080
Combination Product (Y/N)N
Initial Reporter CountryTW
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 07/13/2025
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
Operator of Device Health Professional
Device Model NumberS4708
Device Catalogue NumberS4708
Device Lot Number2108341
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2025
Supplement Date Received by Manufacturer06/10/2025
Initial Report FDA Received Date06/10/2025
Supplement Report FDA Received Date07/14/2025
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured12/17/2021
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 Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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