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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT® IMPLANT; DENTAL IMPLANT
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IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT® IMPLANT; DENTAL IMPLANT Back to Search Results
Catalog Number 603510
Device Problem Device-Device Incompatibility (2919)
Patient Problem Failure of Implant (1924)
Event Date 02/15/2017
Event Type  malfunction  
Event Description
Per the complaint, internal threads stripped.The zest abutment has become loose or come out 3 times.The doctor tried to replace it with a new abutment, which spun out within implant.
 
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Brand Name
REPLANT® IMPLANT
Type of Device
DENTAL IMPLANT
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
Manufacturer Contact
adrienne stott
3050 east hillcrest drive
thousand oaks, CA 91362
8184443300
MDR Report Key7617699
MDR Text Key112037669
Report Number3001617766-2018-00136
Device Sequence Number1
Product Code DZE
UDI-Device Identifier10841307103998
UDI-Public10841307103998
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/20/2021
Device Catalogue Number603510
Device Lot Number80178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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