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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC IMPLANT REMOVAL TOOL; WRENCH
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IMPLANT DIRECT SYBRON MANUFACTURING LLC IMPLANT REMOVAL TOOL; WRENCH Back to Search Results
Catalog Number IXT
Device Problems Fracture (1260); Compatibility Problem (2960)
Patient Problems Failure of Implant (1924); No Information (3190)
Event Date 06/07/2018
Event Type  malfunction  
Event Description
Per complaint (b)(4), an implant failed to integrate and was removed.During the extraction the ixt tool became stuck within the implant and it was fractured.
 
Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated for report submission date and to report device evaluation results.Updated for device return date, for follow-up report submitter, for awareness date and for report type and follow-up number.Updated for follow-up type, for device evaluation status and method, result and conclusion codes.
 
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Brand Name
IMPLANT REMOVAL TOOL
Type of Device
WRENCH
Manufacturer (Section D)
IMPLANT DIRECT SYBRON MANUFACTURING LLC
3050 east hillcrest drive
thousand oaks CA 91362
MDR Report Key8530387
MDR Text Key142488752
Report Number3001617766-2019-00174
Device Sequence Number1
Product Code NDP
UDI-Device Identifier10841307119418
UDI-Public10841307119418
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 05/28/2019
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 No Information
Device Catalogue NumberIXT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Initial Date Manufacturer Received 03/19/2019
Initial Date FDA Received04/19/2019
Supplement Dates Manufacturer Received04/29/2019
Supplement Dates FDA Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
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