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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
Device Problem Incomplete or Missing Packaging (2312)
Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event 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.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation results.
 
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Brand Name
HEX DRILL
Type of Device
HEX DRILL
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest dr.
thousand oaks, CA 91362
8184443300
MDR Report Key8096557
MDR Text Key128268908
Report Number3001617766-2018-00333
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119586
UDI-Public10841307119586
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator 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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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