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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY DRIVER; DENTAL IMPLANT Back to Search Results
Catalog Number HT2.5LG
Device Problem Material Deformation (2976)
Patient Problem Unspecified Infection (1930)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Pma/510(k): not applicable.
 
Event Description
Per complaint (b)(4), during clinical procedure, deformation was observed.
 
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Brand Name
SIMPLYLEGACY DRIVER
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
douglas wilkin
3050 east hillcrest drive
thousand oaks, CA 91362
6614818356
MDR Report Key10973638
MDR Text Key220457819
Report Number3001617766-2020-08574
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119852
UDI-Public10841307119852
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2023
Device Catalogue NumberHT2.5LG
Device Lot Number126095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
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