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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 863713
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Edema (1820); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event 09/08/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017 report late due to asr to individual reporting transition.
 
Event or Problem Description
Per complaint (b)(4) ,during post operative check patient experienced loss or failure of implant to integrate and developed infection about one month after placement.
 
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Brand Name
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 Key8987186
Report Number3001617766-2019-01916
Device Sequence Number16905764
Product Code DZE
UDI-Device Identifier10841307102472
UDI-Public10841307102472
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 Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 09/10/2019
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? No
Operator of Device Health Professional
Device Expiration Date12/13/2021
Device Catalogue Number863713
Device Lot Number85532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/03/2019
Initial Report FDA Received Date09/11/2019
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 Age20 YR
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