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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 604316
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); No Information (3190)
Date of Event 07/28/2011
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), patient experienced failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Upon inspection of the returned part it was established that the part is not manufactured by implant direct.
 
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Brand Name
REPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9178109
Report Number3001617766-2019-04583
Device Sequence Number11405114
Product Code DZE
UDI-Device Identifier10841307104070
UDI-Public10841307104070
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2011
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) 10/21/2019
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 Expiration Date05/13/2015
Device Catalogue Number604316
Device Lot Number26714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Initial Date Received by Manufacturer 09/30/2019
Supplement Date Received by Manufacturer10/15/2019
Initial Report FDA Received Date10/11/2019
Supplement Report FDA Received Date10/21/2019
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 Age28 YR
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