MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. X90 PEDICLE SCREW SYSTEM

Model Number N60000329

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

A company representative reported on (b)(6) 2018, that a distributor may have a possible complaint to report, no other details were provided.The company attempted to retrieve complaint details on (b)(6) 2018, and (b)(6) 2018.On (b)(6) 2018, minimum details regarding the complaint were reported to the company.The complainant reported a patient that presented approximately three months post operative with a broken pedicle screw.There were no identified patient complications.The company attempted to obtain additional complaint details on (b)(6) 2018, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018.The complainant was not responsive.The company reviewed the dhr for the specific complaint lot.There were no manufacturing anomalies identified.The device met all required specifications prior to distribution.The ifu and surgical technique guide for the pedicle screw system provide the required steps and precautions in order to maximize the possibility of a successful outcome with this fixation system.It is unknown if all of the steps and warnings were taken into consideration for this procedure, patient non-compliance, patient health/condition and/or physician error may have contributed to the alleged issue.The company will continue to monitor complaints of this nature.If additional information is received from the complainant, the company will file a follow-up report.

Event Description

The complainant reported a patient that presented approximately three months post operative with a broken pedicle screw.

• Brand Name: X90 PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW 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: 7594416
• MDR Text Key: 110859291
• Report Number: 3005031160-2018-00015
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: M697N600003291
• UDI-Public: M697N600003291
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K052847
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N60000329
• Device Lot Number: 153822
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other