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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL; DENTAL IMPLANT Back to Search Results
Catalog Number HT2.5
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Event date and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Lot information is unknown.If additional information becomes available a supplementary report will be submitted.Pma/510(k): not applicable.(b)(4).
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, product fracture was observed.
 
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Brand Name
HEX TOOL
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key12165873
Report Number3001617766-2021-04163
Device Sequence Number11811856
Product Code NDP
UDI-Device Identifier10841307119630
UDI-Public10841307119630
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberHT2.5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Initial Date Received by Manufacturer 05/10/2021
Supplement Date Received by Manufacturer07/05/2021
Initial Report FDA Received Date07/14/2021
Supplement Report FDA Received Date07/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Weight64
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