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

Catalog Number UNK_SPN

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

The current status and location of the device is unknown.

Event Description

It was reported that a xia 3 screw migrated post-operatively.Revision surgery was conducted approximately 2 months later to replace the screw.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the xia 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.Early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, migration and/or pain.Loss of screw purchase post operatively can be caused by improper screw hole prep, and/or improper screw insertion according to the risk file.Additionally, according to the ifu, early mechanical loosening may result from inadequate initial fixation, latent infection, premature loading of the prosthesis, or trauma.However, the root cause could not be determined conclusively.

Event Description

It was reported that an unknown xia 3 screw migrated 2 months post-operatively.Revision surgery was conducted to replace the screw.

• 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: 10176586
• MDR Text Key: 195904715
• Report Number: 3005525032-2020-00028
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention