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

Model Number	X010-0167
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported difficulties reducing a rod into a pedicle screw.The surgeon was unable to use the persuader or the pistol grip reducer.The surgeon was able to reduce the rod using a rod fork.The rod fork was damaged while reducing the rod.There were no known patient complications.The complaint instruments were not returned for complaint assessment.The complainant provided photos of the instruments.The procedure required posterior instrumentation form t9 to l2.Rod contouring for multi-level instrumentation must be performed so that the apex of a bent rod is not in the locking zone of a pedicle screw.The technique guide instructs the end user to verify that the area around the screw to be free of bony protrusions to ensure full engagement of instruments to the pedicle screw.Additionally, the stg instructs that if unable to reduce, consider additional rod contouring, screw relocation or in situ fusion.Dhr reviews for the persuader and rod fork could not be performed, because the lot number was not provided to the company.The dhr for the persuader was reviewed, and there were not manufacturing anomalies.The persuader met all of the required specifications prior to releasing to distributable inventory.
Event or Problem Description
The complainant reported difficulties reducing a rod into a pedicle screw.The surgeon was unable to use the persuader or the pistol grip reducer.The surgeon was able to reduce the rod using a rod fork.The rod fork was damaged while reducing the rod.There were no known patient complications.

• 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: 8092201
• Report Number: 3005031160-2018-00034
• Device Sequence Number: 19336767
• Product Code: HXE
• UDI-Device Identifier: M697X01001671
• UDI-Public: M697X01001671
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: X010-0167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/20/2018
• 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