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

Model Number	X060-0318
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that when the surgeon pressed the grip-lock inserter to secure the implant, the inserter suddenly broke.There were no reported patient injuries or complications.A visual assessment of the returned grip-lock inserter showed an instrument with repeated use.A functionality assessment could not be performed due to the broken distal tip of the grip-lock inserter.The associated dhr was reviewed, and the device met all required specifications prior to initially being released to distributable inventory.A grip-lock inserter may become broken if excessive force were applied to the handles of the instrument, or if there were lateral force applied to the distal tip of the inserter while engaged with an implant.
Event or Problem Description
The complainant reported that when the surgeon pressed the grip-lock inserter to secure the implant, the inserter suddenly broke.There were no reported patient injuries or 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: 8719641
• Report Number: 3005031160-2019-00029
• Device Sequence Number: 16697180
• Product Code: HTC
• UDI-Device Identifier: M697X06003181
• UDI-Public: M697X06003181
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101471
• 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): 06/20/2019

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: X060-0318
• Device Lot Number: I6249R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/20/2019
• 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