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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 864706
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Failure of Implant (1924); Impaired Healing (2378); Osteopenia/ Osteoporosis (2651)
Date of Event 08/30/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Per complaint (b)(4), after prosthetic treatment, patient experienced loss or failure of implant to integrate.
 
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.
 
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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 Key9171385
Report Number3001617766-2019-04507
Device Sequence Number14085398
Product Code DZE
UDI-Device Identifier10841307102557
UDI-Public10841307102557
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K131097
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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,Followup
Report Date (Section B) 11/01/2019
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 Date12/28/2022
Device Catalogue Number864706
Device Lot Number107062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Initial Date Received by Manufacturer 09/24/2019
Supplement Date Received by Manufacturer11/01/2019
Initial Report FDA Received Date10/09/2019
Supplement Report FDA Received Date11/01/2019
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 Age55 YR
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