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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GODIRECT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC GODIRECT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 433010-ML
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Codes Failure of Implant (1924); No Information (3190)
Date of Event 01/11/2018
Type of Reportable Event Malfunction
Event or Problem Description
According to the complaint, fixation screw was loose and customer didn't understand how to insert.
 
Additional Manufacturer Narrative
Corrected: catalog and udi number.
 
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Brand Name
GODIRECT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key7566786
Report Number3001617766-2018-00137
Device Sequence Number2629663
Product Code DZE
UDI-Device Identifier10841307100225
UDI-Public10841307100225
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Remedial Action Replace,Inspection
Type of Report Initial,Followup
Report Date (Section B) 06/26/2018
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 Expiration Date06/24/2021
Device Catalogue Number433010-ML
Device Lot Number80574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/02/2018
Supplement Date Received by Manufacturer06/14/2018
Initial Report FDA Received Date06/04/2018
Supplement Report FDA Received Date06/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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