MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000137
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complainant communicated to the company on (b)(6) 2020 that a fractured implant screw was identified by x-ray prior to performing a revision procedure on (b)(6) 2020.The fractured screw posed no problems to the patient and was not the reason for revision.The revision procedure was being performed due to non-fusion and adjacent level syndrome, which added hardware to the adjacent level and was backed up posteriorly.The complainant returned the fractured screw to the company on (b)(6) 2020.A dhr review was performed for lot# 170748 and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 6/15/2015.The original c5-c7 procedure was performed on (b)(6) 2015.There were no known patient complications or delay in treatment reported.The revision procedure to extend to adjacent level due to non-fusion was performed on (b)(6) 2020.In the warnings section of the system ifu it states, "internal fixation devices cannot withstand activity and load levels equal to those placed on normal healthy bone.Until maturation of the fusion mass is confirmed do not subject this device to the stress of full weight bearing, or implant failure may result".The possible adverse effects and complications section of the ifu lists "early or late loosening of any or all of the components; disassembly, bending, and/or breakage of any or all of the components; and non-union (pseudarthrosis), delayed union, mal-union." as possible effects and complications for the surgical system.A lack of solid fusion can result in increased stress on implants and may result in implant failure.It is unknown when and how the system screw fractured.
Event or Problem Description
A complainant communicated to the company on (b)(6) 2020 that a fractured implant screw was identified by x-ray prior to performing a revision procedure on (b)(6) 2020.The fractured screw posed no problems to the patient and was not the reason for revision.The revision procedure was being performed due to non-fusion and adjacent level syndrome, which added hardware to the adjacent level and was backed up posteriorly.The complainant returned the fractured screw to the company on (b)(6) 2020.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• MDR Report Key: 9739912
• Report Number: 3005031160-2020-00005
• Device Sequence Number: 11216378
• Product Code: KWQ
• UDI-Device Identifier: M697N600001371
• UDI-Public: M697N600001371
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: N60000137
• Device Lot Number: 170748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/21/2020
• 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
• Patient Age: 42 YR