MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; UNKNOWN ILIAC SCREWS

Catalog Number UNK_SPN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

This record captures a review of 'health-related quality of life outcomes of instrumented circumferential spinal fusion for pediatric spondylolisthesis: a comparison with age and sex matched healthy controls' from the spine journal (volume 45, number 23, pp e1572¿e1579).Twenty-six patients had pedicle screw instrumentation with intercorporeal fusion using tlif cage or autologous structural bone graft.At this time no additional device information is available.The cases in this study range from may 2009-novemeber 2017.It was reported that four patients experienced discomfort from their implanted iliac screws.These devices were later explanted.

Event Description

This record captures a review of 'health-related quality of life outcomes of instrumented circumferential spinal fusion for pediatric spondylolisthesis: a comparison with age and sex matched healthy controls' from the spine journal (volume 45, number 23, pp e1572¿e1579).Twenty-six patients had pedicle screw instrumentation with intercorporeal fusion using tlif cage or autologous structural bone graft.At this time no additional device information is available.The cases in this study range from (b)(6) 2009-(b)(6) 2017.It was reported that four patients experienced discomfort from their implanted iliac screws.These devices were later explanted.

Manufacturer Narrative

The article 'health-related quality of life outcomes of instrumented circumferential spinal fusion for pediatric spondylolisthesis' in spine journal , volume 45 (e1572¿e1579) 2020, was reviewed.Visual, dimensional, material and functional analysis could not be performed as the device was not 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 with the information available.If additional information is received, the investigation will be reopened and updated.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN ILIAC SCREWS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 12084460
• MDR Text Key: 258915813
• Report Number: 3004024955-2021-00014
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other