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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REPLANT IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY REPLANT IMPLANT; DENTAL IMPLANT Back to Search Results
Model Number 606010U
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930)
Date of Event 01/08/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient weight and explant date not provided.
 
Event or Problem Description
As per complaint (b)(4) after a clinical procedure a dental implant displayed a failure of osseointegration and the implant was explanted.Infection was recorded.
 
Additional Manufacturer Narrative
Sections g3 and h5 information provided.
 
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Brand Name
SIMPLY REPLANT IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key10018898
Report Number3001617766-2020-02542
Device Sequence Number2167988
Product Code DZE
UDI-Device Identifier10841307108399
UDI-Public10841307108399
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date (Section B) 05/01/2020
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 Date01/31/2024
Device Model Number606010U
Device Catalogue Number606010U
Device Lot Number133755
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/21/2020
Supplement Date Received by Manufacturer01/21/2020
Initial Report FDA Received Date05/01/2020
Supplement Report FDA Received Date06/02/2020
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 Age32 YR
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