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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS INC. BIOHORIZONS INC.; DENTAL IMPLANT
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BIOHORIZONS INC. BIOHORIZONS INC.; DENTAL IMPLANT Back to Search Results
Model Number IL-5007
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 11/06/2025
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
BIOHORIZONS INC.
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
BIOHORIZONS INC.
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
INTRA-LOCK INTERNATIONAL, INC.
2300 riverchase center
birmingham
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham 
MDR Report Key23733820
Report Number3003631996-2025-00472
Device Sequence Number15890715
Product Code DZE
UDI-Device Identifier00847236016166
UDI-Public00847236016166
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K223697
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
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) 12/31/2025
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 NumberIL-5007
Device Catalogue NumberIL-5007
Device Lot Number2306384
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 11/06/2025
Supplement Date Received by Manufacturer11/12/2025
Initial Report FDA Received Date12/05/2025
Supplement Report FDA Received Date12/31/2025
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured11/27/2023
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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