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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 833211
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 01/28/2019
Type of Reportable Event Malfunction
Event or Problem Description
Per complaint (b)(4), a cover screw fractured within the head of a patient's dental implant during initial placement.The implant was removed along with the fragment.The procedure was completed within the same visit.No adverse patient consequences were reported.
 
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Brand Name
LEGACY 2 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8375587
Report Number3001617766-2019-00070
Device Sequence Number16664558
Product Code DZE
UDI-Device Identifier10841307101604
UDI-Public10841307101604
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 02/27/2019
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 Catalogue Number833211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/29/2018
Initial Report FDA Received Date02/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age73 YR
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