MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. XPRESS MINIMALLY INVASIVE PEDICLE 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)
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 rotating rod inserter had worn laser markings and surface scratches, indicating that the instrument was used repeatedly.One of the prongs at the distal end of the instrument was bent outwards and the other was broken and not present.A dhr review was performed and the instrument met all require specifications prior to being made available for distribution on 7/15/2016.The prongs at the distal tip of a rotating rod inserter may become damaged if the instrument were moved laterally while the attached rod was engaged with a screw extension and pedicle screw construct.Lateral movement while engaged with a screw extension and pedicle screw concentrates applied force to the interface between the rotating rod inserter and rod, which may result in the prongs of the inserter becoming misshaped and broken.The rotating rod inserter was inspected and determined to not be in functional condition and was removed from distributable inventory.
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 SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8457353
• Report Number: 3005031160-2019-00018
• Device Sequence Number: 2888073
• Product Code: HTC
• UDI-Device Identifier: M697T07310001
• UDI-Public: M697T07310001
• 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: T073-1000
• Device Lot Number: XS157167A
• 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