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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 I4713STI
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/06/2024
Type of Reportable Event Serious Injury
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 ctr
birmingham AL 35244
Manufacturer (Section G)
BIOHORIZONS
2300 riverchase ctr
birmingham AL 35244
Manufacturer Contact
anissa smith
2300 riverchase ctr
birmingham, AL 35244
MDR Report Key19051572
Report Number3003631996-2024-00093
Device Sequence Number17980677
Product Code DZE
UDI-Device IdentifierD742I4713STI
UDI-PublicD742I4713STI
Combination Product (Y/N)N
Initial Reporter CountryTW
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 04/05/2024
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 NumberI4713STI
Device Catalogue NumberI4713STI
Device Lot NumberI4713STI
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2024
Initial Report FDA Received Date04/05/2024
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 Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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