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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REACTIVE IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REACTIVE IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 753711U
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 11/03/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), during post operative check,patient experienced failure of implant to integrate.
 
Additional Manufacturer Narrative
This report is submitted late and is captured within capa-(b)(4).
 
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Brand Name
SIMPLY REACTIVE IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9314288
Report Number3001617766-2019-05090
Device Sequence Number19460289
Product Code DZE
UDI-Device Identifier10841307108054
UDI-Public10841307108054
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K080633
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) 04/10/2020
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 Date11/28/2023
Device Model Number753711U
Device Catalogue Number753711U
Device Lot Number128199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Initial Date Received by Manufacturer 10/25/2019
Supplement Date Received by Manufacturer11/20/2019
Initial Report FDA Received Date11/13/2019
Supplement Report FDA Received Date04/10/2020
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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