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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRA-LOCK INTRA-LOCK; DENTAL IMPLANT
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INTRA-LOCK INTRA-LOCK; DENTAL IMPLANT Back to Search Results
Model Number IS3713L
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 05/16/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
 
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Brand Name
INTRA-LOCK
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
INTRA-LOCK
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
BIOHORIZONS INC
2300 riverchase center
birmingham AL
Manufacturer Contact
2300 riverchase center
birmingham, AL 35244
MDR Report Key20251234
Report Number3003631996-2024-00200
Device Sequence Number8163211
Product Code DZE
UDI-Device IdentifierD742IS3713L
UDI-PublicD742IS3713L
Combination Product (Y/N)N
Initial Reporter CountryTW
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 06/15/2024
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 NumberIS3713L
Device Catalogue NumberIS3713L
Device Lot NumberAK300
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 05/16/2024
Initial Report FDA Received Date09/18/2024
Was Device Evaluated by Manufacturer? (Y/N) Yes
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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