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

Model Number	T073-0700
Medical Device Problem Code	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 a serious of broken instruments for replacement.The complainant was unable to provide details regarding the incidents.There were no known patient complications associated with the malfunctions.The following mdrs are related to the receipt of this complaint.3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.The pedicle screw driver was fixed inside a screw extension with a pedicle screw seized to the distal tip of the pedicle screwdriver.The square thread detail of the pedicle screwdriver was broken, which prevented normal disengagement of the driver and screw.The driver showed signs of repeated use as identified by surface scratches, a misshaped distal tip, and worn laser markings.A hardware set tech removed the pedicle screw from the pedicle screwdriver, and the screw extension was determined to pass functional assessment.A dhr review was performed for lot# em13k006 and the device met all required specifications prior to being released to distributable inventory.The pedicle screwdriver was inspected by hardware set tech staff and determined to not be in functional condition and was removed from distributable inventory.Pedicle screwdriver may become damaged if the steps and warnings in the surgical technique guide are not followed.The steps to successfully engage a pedicle screwdriver and pedicle screw are listed in the surgical technique guide, with a warning that states, "failure to use the ratcheting handle when using the pedicle screwdriver at the last step of screw extension assembly may cause damage to the pedicle screwdriver, including damage to the external threading/thread pitch detail.".
Event or Problem Description
The complainant requested to return a serious of broken instruments for replacement.The complainant was unable to provide details regarding the incidents.There were no known patient complications associated with the malfunctions.The following mdrs are related to the receipt of this complaint.3005031160-2019-00013, 3005031160-2019-00014, 3005031160-2019-00015, 3005031160-2019-00016, 3005031160-2019-00017, 3005031160-2019-00018.

• Brand Name: XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8457355
• Report Number: 3005031160-2019-00013
• Device Sequence Number: 13541719
• Product Code: HXX
• UDI-Device Identifier: M697T07307001
• UDI-Public: M697T07307001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/27/2019

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: T073-0700
• Device Lot Number: EM13K006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/27/2019
• 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