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

Model Number	X073-7540-DL
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient initially underwent surgery on (b)(6) 2018, for an l2-3 plif.The patient had been seeing a pain specialist and it was suspected that the fusion at l2-3 was incomplete and that one of the screws was suspected to be loose.The broken screw was identified when it came apart as the surgeon was attempting to remove it on (b)(6) 2019 during a revision procedure.There were no other patient complications reported.The initial reporter indicated that the patient had reportedly slipped on ice and fell on an undisclosed date, however, the incident was not described in the surgeon's notes or the pain management specialist's notes.Non-union of bone fusion, and excessive demands placed on the implant construct may be contributing factors to the broken pedicle screw.Additionally, if the patient did fall as reported, inadvertent patient non-compliance with postoperative management instruction may also be a contributing factor.The instructions for use state that "the patient should be instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation." additionally, listed in the precautions section, "internal fixation devices cannot withstand activity and load levels equal to those placed on normal healthy bone.Until maturation of the fusion mass is confirmed, do not subject this device to the stress of full weight bearing.Or implant failure may result." a visual assessment of the returned pedicle screw identified that the screw was broken at the proximal end of the threading, distal to the spherical screw head.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.The surgeon had a follow-up appointment with the surgeon on (b)(6) 2019 and the patient was reportedly doing well.
Event or Problem Description
The patient initially underwent surgery on (b)(6) 2018, for an l2-3 plif.The patient had been seeing a pain specialist and it was suspected that the fusion at l2-3 was incomplete and that one of the screws was suspected to be loose.The broken screw was identified when it came apart as the surgeon was attempting to remove it on (b)(6) 2019 during a revision procedure.There were no other patient complications reported.

• Brand Name: XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8828789
• Report Number: 3005031160-2019-00035
• Device Sequence Number: 2859653
• Product Code: MNI
• UDI-Device Identifier: M697X0737540DL1
• UDI-Public: M697X0737540DL1
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: X073-7540-DL
• Device Lot Number: 4378-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR