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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 754213U
Medical Device Problem Code Positioning Failure (1158)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's weight was not provided.If the requested information becomes available, a supplementary report will be submitted.(b)(4).
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced lack of primary stability.
 
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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 Key12232428
Report Number3001617766-2021-04395
Device Sequence Number3668472
Product Code DZE
UDI-Device Identifier10841307108115
UDI-Public10841307108115
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
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) 07/27/2021
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 Date04/15/2024
Device Catalogue Number754213U
Device Lot Number136611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/24/2019
Initial Report FDA Received Date07/27/2021
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 Age48 YR
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