MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Device has not been returned for evaluation.

Event Description

It was reported that a patient underwent revision surgery to remove a xia 3 polyaxial screw due, ¿nerve stimulation issues.¿.

Event Description

It was reported that a patient underwent revision surgery to remove a xia 3 polyaxial screw due to ¿nerve stimulation issues.¿.

Manufacturer Narrative

Corrected data: g.1.Has been updated to stryker spine- france from stryker spine- us.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history records and complaint history review could not be performed as a valid catalog number and lot code were not provided and could not be obtained.According to the ifu, while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.Loosening of spinal fixation implants can occur.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.There is not enough information provided to determine a root cause.Nerve stimulation issues could occur if the screw was misplaced and was not fully contained within the pedicle.This could cause the patient to experience pain, weakness, numbness, tingling, etc.In this case, removal could alleviate symptoms.Possible root causes include patient non fusion, length of implantation, patient bone quality, inadequate screw hole prep, patient fall, and/or excessive patient post op activity.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8922248
• MDR Text Key: 155254649
• Report Number: 3004024955-2019-00034
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention