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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
Catalog Number 753713U
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event 07/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).
 
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate and infection.
 
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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 Key10565280
Report Number3001617766-2020-06524
Device Sequence Number16820450
Product Code DZE
UDI-Device Identifier10841307108061
UDI-Public10841307108061
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K080633
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 09/21/2020
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 Date11/17/2024
Device Catalogue Number753713U
Device Lot Number153954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/05/2020
Initial Report FDA Received Date09/22/2020
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 Age44 YR
Patient Weight68
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