MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number N60000463

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Manufacturer Narrative

The complainant reported that a straight pedicle probe was broken.The cap of the pedicle probe came off during a procedure while the surgeon was hammering on the proximal end of the instrument.The complainant added that as the surgeon was trying to remove the probe, the handle began to rotate relative to the shaft.There were no known patient complications.The complaint instrument was inspected and tested.The end cap on the proximal end of the instrument was missing, and there were extensive impact marks where the cap should have been.The handle was able to be removed from the shaft using moderate rotational force.It may be possible that repeated impacts on the instrument may have contributed to the malfunction.This instrument is not intended to be impacted.A dhr review was performed for the complaint instrument and there were no manufacturing anomalies identified.The instrument met all required specifications prior to being released to distributable inventory.

Event Description

The complainant reported that a straight pedicle probe was broken.The cap of the pedicle probe came off during a procedure while the surgeon was hammering on the proximal end of the instrument.The complainant added that as the surgeon was trying to remove the probe, the handle began to rotate relative to the shaft.There were no known patient complications.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW SPINAL 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: 8092218
• MDR Text Key: 128277535
• Report Number: 3005031160-2018-00035
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: M697N600004631
• UDI-Public: M697N600004631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2018

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
• Device Operator: No Information
• Device Model Number: N60000463
• Device Lot Number: 74692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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