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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 423013L
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 09/20/2018
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), a dental implant's head fractured upon placement.The implant was removed and replaced without incident.The patient did not experience any adverse consequences as a result of the event.
 
Additional Manufacturer Narrative
Corrected: device evaluation results.
 
Additional Manufacturer Narrative
Follow-up provided to update device evaluation results.
 
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Brand Name
GODIRECT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 e. hillcrest dr.
thousand oaks CA 91362
MDR Report Key8108575
Report Number3001617766-2018-00339
Device Sequence Number11280083
Product Code DZE
UDI-Device Identifier10841307122005
UDI-Public10841307122005
Combination Product (Y/N)N
Initial Reporter StateID
Initial Reporter CountryUS
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,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup,Followup
Report Date (Section B) 12/12/2018
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 Date07/30/2023
Device Catalogue Number423013L
Device Lot Number119192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Initial Date Received by Manufacturer 10/29/2018
Supplement Date Received by Manufacturer11/28/2018
04/01/2019
Initial Report FDA Received Date11/27/2018
Supplement Report FDA Received Date12/12/2018
04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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