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

Model Number T073-1000

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 8457353
• MDR Text Key: 140129331
• Report Number: 3005031160-2019-00018
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: M697T07310001
• UDI-Public: M697T07310001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other