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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
Model Number 423010L
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); No Information (3190)
Date of Event 10/18/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced loss of implant to osseointegrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated a1 for patient information to include ni for no information available.Updated section b4 for report submission date and b6 to report device evaluation results.Section a2, a3, no information available.Updated d10 for device return date, g1-g2 for follow-up report submitter, g4 for awareness date and g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.This report is submitted late and is captured within capa-1374.
 
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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 Key9390932
Report Number3001617766-2019-05458
Device Sequence Number2491346
Product Code DZE
UDI-Device Identifier10841307121985
UDI-Public10841307121985
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
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) 04/24/2020
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 Health Professional
Device Expiration Date08/19/2024
Device Model Number423010L
Device Catalogue Number423010L
Device Lot Number149265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Initial Date Received by Manufacturer 11/11/2019
Supplement Date Received by Manufacturer12/06/2019
Initial Report FDA Received Date11/29/2019
Supplement Report FDA Received Date04/24/2020
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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