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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 823716
Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 04/24/2018
Event Type  Injury  
Event Description
Per complaint (b)(4), a patient experienced a fracture during a dental implant procedure.An incident of hemorrhaging also occured during the procedure.The implant was removed during the procedure.
 
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Brand Name
LEGACY 2 IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
monica roche
3050 east hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key7787445
MDR Text Key117256039
Report Number3001617766-2018-00188
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307101284
UDI-Public10841307101284
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090234
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 08/15/2018
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
Device Operator Health Professional
Device Expiration Date11/08/2022
Device Catalogue Number823716
Device Lot Number103407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2018
Initial Date FDA Received08/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2017
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 Outcome(s) Required Intervention;
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