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

Model Number N60000107

Device Problem Device Damaged by Another Device (2915)

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

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

No information is provided about the angulation used while preparing the screw holes or placing the screws for the spider plate, and without this information a root cause cannot be determined.The damage found on the plate is consistent with the damage previously seen on spider plates with reported over angulation of at least one screw during screw placement.The over angulation of a spider screw during placement, coupled with over tightening, are the only known factors that can replicate the reported condition of a screw passing through the plate.This suggests the root cause of user error, but there isn't enough information to confirm this as the cause.

Event Description

After performing a discectomy and placing a standard interbody implant, the surgeon chose the size 36mm two level cervical spider plate for implantation.The first screw was placed into the cervical plate and passed directly through the screw hole, providing no fixation.At this point the surgeon decided to not use the spider plate and to use a depuy cervical plate instead.The depuy plate was placed with no further complications.There were no injuries reported.

• Brand Name: SPIDER CERVICAL PLATING (SCP) SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY, CERVICAL
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 452 alexandersville road; miamisburg OH 45342
• Manufacturer Contact: charlene brumbaugh ; 452 alexandersville road; miamisburg, OH 45342 ; 9378478400
• MDR Report Key: 6790036
• MDR Text Key: 82674417
• Report Number: 3005031160-2017-00153
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N60000107
• Device Lot Number: 165803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR