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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
Model Number HT2.0SG
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lot information unknown and if it becomes available a follow-up report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure, driver broke off in the implant.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated g1-g2 for follow-up report submitter and g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.A4 patient weight, not provided.
 
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Brand Name
SIMPLYLEGACY DRIVER
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks, ca
MDR Report Key9710738
Report Number3001617766-2020-01467
Device Sequence Number18921258
Product Code NDP
UDI-Device Identifier10841307119821
UDI-Public10841307119821
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
NA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberHT2.0SG
Device Catalogue NumberHT2.0SG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Initial Date Received by Manufacturer 01/24/2020
Supplement Date Received by Manufacturer01/24/2020
Initial Report FDA Received Date02/14/2020
Supplement Report FDA Received Date06/01/2020
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 Age68 YR
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