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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX DRILL
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IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX DRILL Back to Search Results
Catalog Number HD2.7
Medical Device Problem Code Incomplete or Missing Packaging (2312)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), a missing o-ring on a hex drill caused the dentist to drop a dental implant inside the patient's mouth during placement.The procedure was completed within the same procedure with another implant.There was no patient impact as a result of the event.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation results.
 
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Brand Name
HEX DRILL
Common Device Name
HEX DRILL
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8096557
Report Number3001617766-2018-00333
Device Sequence Number2745816
Product Code NDP
UDI-Device Identifier10841307119586
UDI-Public10841307119586
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
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) 01/24/2019
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 Expiration Date06/21/2023
Device Catalogue NumberHD2.7
Device Lot Number118929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Initial Date Received by Manufacturer 10/23/2018
Supplement Date Received by Manufacturer01/22/2019
Initial Report FDA Received Date11/21/2018
Supplement Report FDA Received Date01/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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