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

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant stated that the patient presented with right flank pain and low back pain during a six-month post-operative virtual visit on (b)(6) 2018.The patient had ct scan imaging performed on (b)(6) 2018 which was forwarded to the company for review on 08/03/2018.Part numbers and lot numbers associated with this product complaint were not provided.The complainant was unable to provide information on the patient's health status or the necessity for revision surgery.The surgeon stated that the ct shows non-union at l2/3 with right side broken screw, severe right l3/4 foraminal stenosis, discussed direct lateral approach to re-fuse, but not sure this is definitively causing his pain.The surgeon stated that the patient was going to be given a right l3/4 injection, if the injection does not relieve the pain, a revision surgery will be discussed.The complainant had a meeting scheduled with the surgeon on (b)(6) 2018.The company will file a follow-up report if more information is received.The company's review of the ct images did not reveal any anatomical or placement issues, the screw and rod system appeared to be appropriately used and implanted.The broken pedicle screw was identified at the bottom of the construct at l3, at approximately half length of the screw shank.

Event Description

The complainant reported a broken/fractured screw was found on a ct scan performed on a patient during a visit due to discomfort aproximately six months after surgery.

• 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: 7802463
• MDR Text Key: 118107934
• Report Number: 3005031160-2018-00024
• Device Sequence Number: 1
• Product Code: NKB
• 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: Other
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other