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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 805708
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Codes Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event 02/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product received without claim form.Information was requested and it was noted that the part number and lot number did not match the product that was returned for evaluation.Follow-up request for information was submitted.
 
Event or Problem Description
As per complaint (b)(4), after a clinical procedure a dental implant had a failure to osseointegrate and was explanted.
 
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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 Key9293791
Report Number3001617766-2019-02259
Device Sequence Number2362341
Product Code DZE
UDI-Device Identifier10841307100935
UDI-Public10841307100935
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
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 health professional,user faci
Initial Reporter Occupation Dentist
Remedial Action Inspection
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Date12/09/2023
Device Catalogue Number805708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/14/2019
Initial Report FDA Received Date11/07/2019
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 Age71 YR
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