MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0440
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon attempted to place a 3.5mm certex screw in the cervical spine and the screw would not disengage from the driver.The screw was then explanted.When the surgeon examined the driver, it was missing part of the metal band just under the threads.A new screw was placed with another driver.There was no harm to the patient and any delay was negligible.The complaint instrument was received and a visual inspection was performed, the instrument was as described by the complainant.The pedicle screw was returned with the driver, and it will not disengage from the broken square thread assembly.A funtionality test could not be performed.A dhr review was reviewed for both the driver and the pedicle screw.There were no manufacturing anomalies identified, and the parts met all the required specifications prior to being released for distribution.The corresponding surgical technique guides outline the steps that must be performed to correclty load and place pedicle screws.It is unclear if all steps in the surgical techniqure guide were followed when loading and placing the pedicle screw.
Event or Problem Description
The surgeon attempted to place a 3.5mm certex screw in the cervical spine and the screw would not disengage from the driver.The screw was then explanted.When the surgeon examined the driver, it was missing part of the metal band just under the threads.A new screw was placed with another driver.There was no harm to the patient and any delay was negligible.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7469396
• Report Number: 3005031160-2018-00010
• Device Sequence Number: 107343
• Product Code: HXX
• UDI-Device Identifier: M697X06704401
• UDI-Public: M697X06704401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: X067-0440
• Device Lot Number: 055732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/27/2018
• 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: Other