MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC IMPLANT REMOVAL TOOL; WRENCH

Catalog Number	IXT
Medical Device Problem Codes	Fracture (1260); Compatibility Problem (2960)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.

• Brand Name: IMPLANT REMOVAL TOOL
• Common Device Name: WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8530387
• Report Number: 3001617766-2019-00174
• Device Sequence Number: 13828328
• Product Code: NDP
• UDI-Device Identifier: 10841307119418
• UDI-Public: 10841307119418
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Catalogue Number: IXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR