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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 474708
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event 02/02/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product received without claim form.Information was requested and it was noted that the part number and lot number did not match the product that was returned for evaluation.Follow-up request for information was submitted.
 
Event or Problem Description
Per complaint (b)(4), after the clinical procedure an implant failed and was removed.
 
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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 Key9293681
Report Number3001617766-2019-02315
Device Sequence Number2195662
Product Code DZE
UDI-Device Identifier10841307100157
UDI-Public10841307100157
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Catalogue Number474708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/08/2019
Initial Report FDA Received Date11/07/2019
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 Age66 YR
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