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

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problem Vertebral Fracture (4520)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

The article 'minimally invasive transforaminal lumbar interbody fusion using augmented reality surgical navigation for percutaneous pedicle screw placement' in clinical spine surgery, volume 34, number 7, august 2021, was reviewed.The aim of this study was to evaluate the accuracy of percutaneous pedicle screw placement using augmented reality surgical navigation during minimally invasive transforaminal lumbar interbody fusion (tlif).The study assessed percutaneous pedicle screw placement in 20 consecutive patients who underwent single-level minimally invasive tlif using augmented reality surgical navigation.Facet joint violation and depression by the inserted pedicle screws were evaluated.Secondary outcome such as radiation dose exposure, fluoroscopy time, and operative time were collected for 3 phases of surgery: preparation phase, pedicle screw placement, and decompression with cage placement.All cases utilized the es2 system.A total of 80 percutaneous pedicle screws (4 per patient) were placed in 20 patients with a majority of l4¿ l5 fusion (70%).There were 15 females and 5 males with an average age of 69.5 ± 9.8 years.The rate of accurately placed pedicle screws (grades 0 and 1) was 94%.There was no severe violation above 4 mm (grade 3), 16% of the screws breached the pedicle < 2 mm (grade 1) and 6% between 2 and 4 mm (grade 2), respectively.Among the 18 breaches, 3 (17%) were caudal or medial, the rest were cranial or lateral.No endplate violation was observed in case of cranial or caudal trajectory misalignment.One medial breach was a grade 2 demonstrating a 2 mm breach of a l5 pedicle which was deemed intraoperatively during subsequent decompression and tlif placement as safe and not requiring revision.Intra-articular facet joint violation was observed for 1 screw.This report captures 18 pedicle breaches; 3 caudal/medial, 15 cranial/lateral.Because limited information is available about each individual event, per fda guidance, one mdr is being submitted to capture these 18 serious injuries.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19113188
• MDR Text Key: 340224958
• Report Number: 0009617544-2024-00040
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• 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