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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 3 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLY LEGACY 3 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 857008U
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 05/12/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Patient's identifier, age, weight, date of event were not provided.When the requested information becomes available, a supplementary report will be submitted.
 
Event or Problem Description
Per complaint (b)(4), during clinical procedure patient experienced product failure.
 
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Brand Name
SIMPLY LEGACY 3 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key11884398
Report Number3001617766-2021-03081
Device Sequence Number3685801
Product Code DZE
UDI-Device Identifier10841307107996
UDI-Public10841307107996
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K192221
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
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) 05/26/2021
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 Date02/21/2026
Device Catalogue Number857008U
Device Lot Number178243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/17/2021
Initial Report FDA Received Date05/26/2021
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;
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