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

Model Number	T073-1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that while inserting a rod, the distal tip of an inserter broke.The surgeon was able to successfully finish the surgery.There were no known patient complications.The instrument has not been received for complaint investigation.Pictures of the device depicted one of the distal hooks of the inserter broken from the instrument.A dhr review was performed.The instrument met all required specifications prior to being released to distributable inventory on 06/20/2016.A lateral force applied to the inserter while placing a rod into a pedicle screw may have caused the damage to the inserter.Application of lateral force to the inserter concentrates force to the interface between the inserter and rod.
Event or Problem Description
The complainant reported that while inserting a rod, the distal tip of an inserter broke.The surgeon was able to successfully finish the surgery.There was no harm to the patient.

• Brand Name: XPRESS MINIMALLY INVASIVE PEDICEL 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: 8471542
• Report Number: 3005031160-2019-00019
• Device Sequence Number: 19240957
• Product Code: HTC
• UDI-Device Identifier: M697T07310001
• UDI-Public: M697T07310001
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 04/01/2019

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: T073-1000
• Device Lot Number: XS157167A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/01/2019
• 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