MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number	X060-0241
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned set screw identified an implant fracture as reported.The top portion of the set screw was sheared off at approximately half the depth of the torx detail.A functionality assessment could not be performed due to the damaged condition of the set screw.A dhr review was performed for the complaint lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 12/19/19.There have not been any other reported complaints with this lot.Experienced hardware staff were consulted for input regarding the implant set screw malfunction.None of the company staff had previously seen a set screw malfunction in this manner.The set screw is used to secure the cross bar implant to the locking plate, which is distributed with the set screw contained within the threaded hole of the implant when distributed.When rotational force is applied to the set screw, it is almost completely captured within the threaded hole of the implant.It is unclear how a system set screw could be fractured when being tightened.It could be possible that a set screw may fracture if excessive rotational force was applied or if it was rotated while cross-threaded in the implant.Excessive rotational force may fracture the set screw.A torque-limiting handle is provided to limit the amount of rotational force applied to the set screw.A cross-threaded set screw would not rotate as intended and may concentrate applied force and result in a malfunction.It is unclear how a set screw could be cross-threaded.The implant is provided as an assembly, which includes the set screw contained within the threaded hole of the implant.
Event or Problem Description
The company received notification on 4/29/2020 regarding an implant set screw that fractured when it was tightened during a surgical procedure on (b)(6) 2020.There were no known patient complications associated with this product complaint.A set screw from an alternate implant was used to successfully complete the procedure.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• MDR Report Key: 10099297
• Report Number: 3005031160-2020-00016
• Device Sequence Number: 3386702
• Product Code: PEK
• UDI-Device Identifier: M697X06002411
• UDI-Public: M697X06002411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: X060-0241
• Device Lot Number: 15931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/28/2020
• 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: 73 YR