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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 854706
Device Problems Break (1069); Separation Problem (4043)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 04/23/2019
Event Type  Injury  
Event Description
Per complaint (b)(4), a hex tool broke within a dental implant during the implant procedure.The tool was stuck within the top part of the implant.The patient's bone was drilled as a consequence.
 
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Brand Name
LEGACY 3 IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest dr.
thousand oaks CA 91362
Manufacturer Contact
monica roche
3050 east hillcrest dr.
thousand oaks, CA 91362
8184443300
MDR Report Key8761132
MDR Text Key150120374
Report Number3001617766-2019-00293
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307102151
UDI-Public10841307102151
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
K131097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date 07/03/2019
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
Device Operator Health Professional
Device Expiration Date10/18/2023
Device Catalogue Number854706
Device Lot Number125596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Initial Date Manufacturer Received 06/03/2019
Initial Date FDA Received07/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2018
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 Outcome(s) Required Intervention;
Patient Age70 YR
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