MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. X90 PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	N60000328
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that pedicle screws were extremely difficult to lock and when the rod is slightly bent, the surgeon cannot lock the screws.There were no known patient complications.This mdr corresponds with mdr 3005031160-2019-00021.Further communications with the complainant indicated that the screws were part of a larger six screw construct.The complainant stated that two screws ended up not locking at all, but all of the 6.5mm x 45mm screws are extremely difficult to lock.The rod sits up higher on these screws and the locking wrench slips off the top of the screw easily and wears the locking wrench out.The surgeon was confident that the construct would be successful.The surgical technique guide provides guidance on successfully placing and final locking pedicle screws.The surgical technique guide includes a cautionary statement that says, "avoid placement of a bent-rod apex in the locking zine of a screw.A bent rod in the locking zone of a pedicle screw would prevent the screw from final locking, as a bent rod does not fit within the pedicle screw cup." if further information becomes available, a follow-up mdr will be submitted.
Event or Problem Description
The complainant reported that pedicle screws were extremely difficult to lock and when the rod is slightly bent, the surgeon cannot lock the screws.There were no known patient complications.This mdr corresponds with mdr 3005031160-2019-00021.

• Brand Name: X90 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: 8547112
• Report Number: 3005031160-2019-00022
• Device Sequence Number: 2430979
• Product Code: MNI
• UDI-Device Identifier: M697N600003281
• UDI-Public: M697N600003281
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 04/24/2019

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: N60000328
• Device Lot Number: 056339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/24/2019
• 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: Other