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

Model Number	T073-0700
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 complainant requested to return broken screwdriver assemblies to the company.Additional information was requested by the company.The complainant responded stating that the damage occured when the surgeon was locking the screw.There was no harm done to the patient, and there were no other complications.The devices (2) were inspected and it was confirmed that there was damage to the threads on the distal tip of the driver assemblies.The visual inspection identified signs of frequent use.A dhr review was performed and there were no manufacturing anomalies identified.The damage to the threads could have been caused by over torquing the handle attached to the driver.
Event or Problem Description
The complainant requested to return broken screwdriver assemblies to the company.Additional information was requested by the company.The complainant responded stating that the damage occured when the surgeon was locking the screw.There was no harm done to the patient, and there were no other 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: 7375305
• Report Number: 3005031160-2018-00003
• Device Sequence Number: 13746386
• Product Code: HXX
• UDI-Device Identifier: M697T07307001
• UDI-Public: M697T07307001
• Combination Product (Y/N): N
• 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,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: T073-0700
• Device Lot Number: EM13K006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/27/2018
• 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