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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY ZIRCONIA ABUTMENT BASE; DENTAL IMPLANT

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IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY ZIRCONIA ABUTMENT BASE; DENTAL IMPLANT Back to Search Results
Catalog Number 8035-30CB
Device Problem Loss of Osseointegration (2408)
Patient Problem Failure of Implant (1924)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.
 
Event Description
Per (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.
 
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Brand Name
LEGACY ZIRCONIA ABUTMENT BASE
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key10834832
MDR Text Key216088629
Report Number3001617766-2020-07950
Device Sequence Number1
Product Code NHA
UDI-Device Identifier10841307112006
UDI-Public10841307112006
Combination Product (y/n)N
PMA/PMN Number
K143011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/28/2023
Device Catalogue Number8035-30CB
Device Lot Number116195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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