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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 424710
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 06/20/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during laboratory procedure, patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
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 Key9392118
Report Number3001617766-2019-05502
Device Sequence Number19455523
Product Code DZE
UDI-Device Identifier10841307100164
UDI-Public10841307100164
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 04/29/2020
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 Model Number424710
Device Catalogue Number424711
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Initial Date Received by Manufacturer 11/13/2019
Supplement Date Received by Manufacturer12/05/2019
Initial Report FDA Received Date11/30/2019
Supplement Report FDA Received Date04/29/2020
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;
Patient Age45 YR
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