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

Model Number	X060-0320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the t-handle in their possession is out of calibration and resulted in two screwdrivers breaking.There were no known patient complications.The company made multiple attempts to gather complaint details and request the complaint parts be returned for complaint assessment.The complainant stated that they intended to return the instruments, however, to-date, they have not been received, no additional details have been provided.The calibration of the t-handle has not been assessed by the company, and it cannot been confirmed if it is out of calibration.Dhr reviews could not be completed due to the lot numbers not being provided.
Event or Problem Description
The complainant reported that the t-handle in their possession is out of calibration and resulted in two screwdrivers breaking.There were no known patient complications.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: INTERSPINOUS PROCESS FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8197729
• Report Number: 3005031160-2018-00038
• Device Sequence Number: 267860
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2018

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: X060-0320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/26/2018
• 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