MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. XPRESS MINIMALLY INVASIVE PEDICEL 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 Date 03/02/2019

Event Type  malfunction  

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 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
• 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: 8471542
• MDR Text Key: 140616434
• Report Number: 3005031160-2019-00019
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: M697T07310001
• UDI-Public: M697T07310001
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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?: No
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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