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

Model Number T066-0059

Device Problem Solder Joint Fracture (2324)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

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 Description

This medical device report is associated with mdr number 3005031160-2020-00013, where it was reported that a forceps implant inserter malfunctioned while in use.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.The second malfunction was not reportedly involved in a surgical procedure.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, mt ; 3880480112
• MDR Report Key: 10089906
• MDR Text Key: 199713922
• Report Number: 3005031160-2020-00014
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: M697T06600591
• UDI-Public: M697T06600591
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other