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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT ZIRCONIA ABUTMENT BASE; DENTAL ABUTMENT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT ZIRCONIA ABUTMENT BASE; DENTAL ABUTMENT Back to Search Results
Catalog Number 6050-30CB
Medical Device Problem Code Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/14/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Conclusion code: cause traced to packaging.
 
Event or Problem Description
Per complaint (b)(4), an abutment base of the wrong size was in a correctly ordered package.The problem was discovered while unpacking.There was no patient involvement.
 
Additional Manufacturer Narrative
Follow-up submission is to correct part number to 6050-30cb and conclusion code.Conclusion code: cause traced to packaging 6050-35cb abutment was received in 6035-30cb packaging.
 
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Brand Name
REPLANT ZIRCONIA ABUTMENT BASE
Common Device Name
DENTAL ABUTMENT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8166322
Report Number3001617766-2018-00372
Device Sequence Number11449388
Product Code NHA
UDI-Device Identifier10841307114024
UDI-Public10841307114024
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K143011
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial,Followup
Report Date (Section B) 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date03/12/2023
Device Catalogue Number6050-30CB
Device Lot Number111114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Initial Date Received by Manufacturer 11/14/2018
Supplement Date Received by Manufacturer11/14/2018
Initial Report FDA Received Date12/14/2018
Supplement Report FDA Received Date12/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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