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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 6035-30CB
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 12/17/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluation not possible due to the product being discarded.
 
Event Description
Per complaint (b)(4), a 6035-30cb dental abutment base did not fit the respective analog.The label was correct, but the incorrect part was received.
 
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Brand Name
REPLANT ZIRCONIA ABUTMENT BASE
Type of Device
DENTAL ABUTMENT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
monica roche
3050 east hillcrest dr.
thousand oaks, CA 91362
8184443300
MDR Report Key8251171
MDR Text Key133214788
Report Number3001617766-2019-00025
Device Sequence Number1
Product Code NHA
UDI-Device Identifier10841307114024
UDI-Public10841307114024
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Remedial Action Inspection
Type of Report Initial
Report Date 01/15/2019
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
Device Operator Other
Device Expiration Date03/12/2023
Device Catalogue Number6035-30CB
Device Lot Number111114
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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