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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC STEP DRILL (6-16MML)
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IMPLANT DIRECT SYBRON MANUFACTURING LLC STEP DRILL (6-16MML) Back to Search Results
Model Number SD2.3
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Codes Failure of Implant (1924); No Information (3190)
Date of Event 12/20/2017
Type of Reportable Event Serious Injury
Event or Problem Description
While doing guided surgery the doctor found the drills wouldn't move through the inserts past were the narrow apex meets the wider part of drill.Because doctor had to skip drill in the sequence they couldn't get the correct size osteotomy and the implant couldn't achieve stability.This is a reportable serious injury and device malfunction, requiring second surgery to complete the procedure.
 
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Brand Name
STEP DRILL (6-16MML)
Common Device Name
STEP DRILL
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key7503411
Report Number3001617766-2018-00109
Device Sequence Number19210454
Product Code DZI
UDI-Device Identifier10841307117148
UDI-Public10841307117148
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K081396
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 05/10/2018
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 Dentist
Device Model NumberSD2.3
Device Catalogue NumberSD2.3
Device Lot Number60702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/20/2017
Initial Report FDA Received Date05/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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