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

Model Number	X060-0320
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a screwdriver broke while removing a cross bar connector between l3 and l4.There were no known patient complications associated with this incident.The complainant confirmed that the removal of the cross bar connector was performed due to adjacent level disease.A dhr review was performed for the device.There were no manufacturing anomalies identified.The device met all required specifications prior to release to distributable inventory.The driver that was used to remove the cross bar connector was not the appropriate driver that was intended to perform the function.This may have caused or contributed to the incident.
Event or Problem Description
The complainant reported that a screwdriver broke while removing a cross bar connector between l3 and l4.There were no known patient complications associated with this incident.

• 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: 7683123
• Report Number: 3005031160-2018-00020
• Device Sequence Number: 19175001
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/12/2018

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
• Device Lot Number: 60190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/12/2018
• 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