MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T066-0059
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A physical assessment of the device identified that the weld does not cover the circumference of the entire impaction plate assembly, whereas, the welds from other lots of the same device do.In addition to the weld not covering the entire circumference of the impaction plate assembly, it is suspected that there was not sufficient penetration between of the weld to the base instrument, or of the weld to the impaction plate assembly.When reviewing the engineering drawing, it does not specify that the weld should cover the entire circumference of the impaction plate assembly, however it does state: "all welds to be completely sealed, free of gaps and seams, and polished to a satin finish".
Event or Problem Description
The company received notification on 5/05/2020 regarding a forceps implant inserter that was reported to have the impaction plate fracture from the instrument with minimal striking force during a surgical procedure on (b)(6) 2020.The procedure was successfully completed, there were no known patient complications.The complainant assessed a second forceps inserter (from the same lot) and found that the same failure was achieved with minimal force applied by hand.Report 3005031160-2020-00014 has been submitted for the second device.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• MDR Report Key: 10089904
• Report Number: 3005031160-2020-00013
• Device Sequence Number: 2653506
• Product Code: OVE
• UDI-Device Identifier: M697T06600591
• UDI-Public: M697T06600591
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Replace
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: Health Professional
• Device Model Number: T066-0059
• Device Lot Number: XS1920458A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/26/2020
• 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: Other
• Patient Age: 63 YR