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 08/01/2015

Event Type  Injury  

Event Description

The article 'the accuracy and safety of fluoroscopically guided percutaneous pedicle screws in the lumbosacral junction and the lumbar spine' in the bone and joint journal 2015; 97-b:1111¿17, was reviewed.This was a retrospective evaluation study undertaken in two study populations involving 203 patients (mean age 58.8 years; 16 to 91, 103 male, 100 female) and 880 lumbosacral junction and lumbar percutaneous pedicle screws.Surgeries were performed between january 2008 and december 2012 in consecutive patients.Mantis systems were used in all cases.Screws with perforations were classified into two types.For medial, lateral, superior and inferior perforations, the pedicle perforations were assessed using gertzbein and robbin¿s classification as modified by rao.For anterior perforations, the pedicle perforations were assessed using a modified grading system.Grade 2 perforations were considered to have possible complications and grade 3 were considered critical perforations with a high risk of early or late complications.There were a total of 48 lateral perforations, 22 anterior perforations, 11 medial perforations, 4 superior perforations and 2 inferior perforations.One patient (f, 73 years old) was diagnosed with spinal metastases, with l1 and l3 pathological fractures causing back pain, instability and cauda equina syndrome.Mist was performed using fluoroscopically guided percutaneous pedicle screw insertion at t11, t12, l2, l4 and l5, with laminectomy at l3.The left l2 pedicle screw showed grade 3 lateral perforation on the post-operative ct scans.The patient developed no complications.

Manufacturer Narrative

H3 other text: device location unknown.

• 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: 19177431
• MDR Text Key: 341002729
• Report Number: 0009617544-2024-00052
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/24/2024
• 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): Other