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

Model Number	T066-0074
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant requested to return a screwdriver that reportedly failed due to wear and tear.There were no reported patient complications.A visual assessment of the returned driver indicated frequent use.The tin coating at the distal tip of the driver was worn and the distal hex tip was broken from the driver.A functionality test could not be performed due to the damage.It is possible that the distal hex tip of the driver could break if it were rotated while not fully seated in the screw head or rotated while engaged with the screw head at an angle.The driver tip could break if excessive rotational force were applied.It could be possible to apply excessive rotational force if the patient had very dense bone and the drilling and tapping steps were being performed with the self-drilling screws or self-tapping screws.The drilling and tapping steps to prepare patient bone can be performed with dedicated instruments within the surgical system or with the self-drilling and self-tapping screws.A dhr review was performed and the device met all required specifications prior to being initially released to distribution on 05/05/2014.
Event or Problem Description
The complainant requested to return a screwdriver that reportedly failed due to wear and tear.There were no reported patient complications.

• 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 59714
• MDR Report Key: 8947739
• Report Number: 3005031160-2019-00042
• Device Sequence Number: 2559629
• Product Code: HXX
• UDI-Device Identifier: M697T06600741
• UDI-Public: M697T06600741
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: Health Professional
• Device Model Number: T066-0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/29/2019
• 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: Other