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

Model Number	N60000329
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The complainant reported a patient that presented approximately three months post operative with a broken pedicle screw.

• Brand Name: X90 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: 7594416
• Report Number: 3005031160-2018-00015
• Device Sequence Number: 16597803
• Product Code: MNI
• UDI-Device Identifier: M697N600003291
• UDI-Public: M697N600003291
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K052847
• 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): 06/12/2018

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: N60000329
• Device Lot Number: 153822
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/12/2018
• 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