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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 1 IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 805713
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event 08/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lot information provided by complainant does not match the part number.Information is unknown.
 
Event or Problem Description
Per complaint (b)(4), during laboratory procedure, patient experienced loss or failure of implant to integrate.
 
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Brand Name
LEGACY 1 IMPLANT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key9487382
Report Number3001617766-2019-05901
Device Sequence Number16447819
Product Code DZE
UDI-Device Identifier10841307100966
UDI-Public10841307100966
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
K061319
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 12/18/2019
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 Catalogue Number805713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/18/2019
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 Age48 YR
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