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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
Model Number 864213
Medical Device Problem Code Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event 10/17/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), the patient experience intermittent painful sensation apically and facially.The patient wanted the implant explanted after surgical re-entry did not resolve issue.
 
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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 Key8116956
Report Number3001617766-2018-00347
Device Sequence Number1516473
Product Code DZE
UDI-Device Identifier10841307102533
UDI-Public10841307102533
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K090234
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 11/29/2018
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
Operator of Device Health Professional
Device Expiration Date09/22/2021
Device Model Number864213
Device Catalogue Number864213
Device Lot Number83256
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/30/2018
Initial Report FDA Received Date11/29/2018
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 Age44 YR
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