MAUDE Adverse Event Report: UNKNOWN_SPINE_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPN

Device Problems Malposition of Device (2616); Insufficient Information (3190); Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

This record captures a review of 'safety and efficacy of single-stage versus 2-stage spinal fusion via posterior instrumentation and anterior thoracoscopy: a retrospective matched-pair cohort study with 247 consecutive patients' from the journal of world neurosurgery (world neurosurg./2018) 109:e739-e747.Https.//doi.Org/10.1016/j.Wneu.2017.10.074).There were 247 patients over 7 years who underwent 1-stage or 2-stage stabilization with thoracoscopic fusion.Forty-seven patients required revision surgery relating to either misplacement/loosening or failure of their mantis, xia, or vlift implants.Additional information is not available at this time, it is not clear which implants experienced failure.This report captures the xia implants.

Manufacturer Narrative

The article 'safety and efficacy of single-stage versus 2-stage spinal fusion via posterior instrumentation and anterior thoracoscopy: a retrospective matched-pair cohort study with 247 consecutive patients' in the journal of world neurosurgery, volume 109 (e739-e747) 2018, was reviewed.This record addresses intra-operative implant misplacement and post-operative loosening for the xia spinal system implants used.Visual, dimensional, material and functional analysis could not be performed as no devices were returned.  device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received the investigation will be reopened and updated.

Event Description

This record captures a review of 'safety and efficacy of single-stage versus 2-stage spinal fusion via posterior instrumentation and anterior thoracoscopy: a retrospective matched-pair cohort study with 247 consecutive patients' from the journal of world neurosurgery (world neurosurg./2018) 109:e739-e747.Https.//doi.Org/10.1016/j.Wneu.2017.10.074).There were 247 patients over 7 years who underwent 1-stage or 2-stage stabilization with thoracoscopic fusion.Forty-seven patients required revision surgery relating to either misplacement/loosening or failure of their mantis, xia, or vlift implants.Additional information is not available at this time, it is not clear which implants experienced failure.This report captures the xia implants.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 12084704
• MDR Text Key: 258945909
• Report Number: 0009617544-2021-00118
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention