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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYINTERACTIVE DRIVER; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYINTERACTIVE DRIVER; DENTAL IMPLANT Back to Search Results
Catalog Number HT2.3LG
Medical Device Problem Codes Fracture (1260); Positioning Problem (3009)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 09/15/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's age was not provided.When the requested information becomes available, supplementary report will be submitted.Pma/510(k) - not applicable.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, product fractured.
 
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Brand Name
SIMPLYINTERACTIVE DRIVER
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key10828230
Report Number3001617766-2020-07911
Device Sequence Number19740511
Product Code NDP
UDI-Device Identifier10841307119838
UDI-Public10841307119838
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
NA
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) 11/12/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date03/27/2024
Device Catalogue NumberHT2.3LG
Device Lot Number138488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2020
Initial Report FDA Received Date11/12/2020
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 Weight93
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