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

Model Number X073-5545

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/26/2014

Event Type  Injury  

Manufacturer Narrative

The root cause cannot be reliably determined due to a lack of information.No medical images were received.Pseudarthrosis is the suspected reason for the screw breakage.

Event Description

In 2014 during a l5 to s1 fusion, surgeon number one implanted xpress screws within a patient.A single screw fractured at some point later at l5 on the left side.Representative mentioned that he thought this was a case of the hardware giving out due to an overweight patient.On (b)(6) 2017, the broken screw was removed by surgeon number two, with no complications during the revision surgery.Representative is sending the removed screws back, but he does not have any additional information.

• Brand Name: XPRESS PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL FIXATION
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• Manufacturer Contact: kriss anderson ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 6683113
• MDR Text Key: 78896439
• Report Number: 3005031160-2017-00144
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: X073-5545
• Device Lot Number: 2202-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR