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

Model Number X060-0320

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

The complainant reported that they had screwdrivers that were reported to be broken and twisted.The complainant was unable to provide specific details regarding the instruments.There were no known patient complications.The complaint instruments have not been returned for complaint investigation.Upon receipt and evaluation of the complaint instruments, follow-up mdr(s) will be submitted as necessary.

Event Description

The complainant reported that they had screwdrivers that were reported to be broken and twisted.The complainant was unable to provide specific details regarding the instruments.There were no known patient complications.

Manufacturer Narrative

The instruments were returned for complaint assessment on 04/12/2019.The assessment of the devices did not detect a malfunction.

• 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
• MDR Report Key: 8454574
• MDR Text Key: 139976314
• Report Number: 3005031160-2019-00012
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (y/n): N
• PMA/PMN Number: K101471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

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
• Device Operator: Health Professional
• Device Model Number: X060-0320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 02/24/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other