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

Model Number X060-0318

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2019

Event Type  malfunction  

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 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
• Type of Device: INTERSPINOUS PROCESS FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 8719641
• MDR Text Key: 149368770
• Report Number: 3005031160-2019-00029
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: M697X06003181
• UDI-Public: M697X06003181
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other