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 Spinal Cord Injury (2432)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

The article 'patient-reported outcomes of minimally invasive versus open transforaminal lumbar interbody fusion for degenerative lumbar disc disease: a prospective comparative cohort study' in clinics in orthopedic surgery 2023 apr;15(2):257-264, was reviewed.A prospective cohort study was performed, comparing 54 patients who underwent o-tlif and 55 patients who underwent mi-tlif with a follow-up of 4 years.Clinical evaluation was performed using the oswestry disability index (odi), 36-item short form survey (sf-36), and a visual analog scale for pain (vas pain).A single surgeon performed all the surgeries.In both groups, standard decompressions, placement of a peeking interbody cage (avs navigator system) with autologous bone graft obtained from the removed facet, and fixation with pedicle screws and rods were carried out.Demineralized bone matrix (grafton; medtronic) was added in 8 patients.Cage position was checked under fluoroscopy.Then, the screws were connected to rods (xia 3).The mi-tlif procedure was performed with small incisions on the lateral pedicle lines for placement of the pedicle cannulated screws under fluoroscopy control.The minimally invasive system used was the lite system.Using small paramedian incisions and sequential tubular dilators, facetectomies, decompression, discectomy, and endplate preparation were done.Cage insertion was carried out with an autologous bone graft.Screws and rods (es2) were placed percutaneously on both sides.Initially, 114 patients were included in the study, 57 in each group.In the o-tlif group, 1 patient died during the follow-up for a reason not related to the surgery, and 2 patients were lost to follow-up.In the mi-tlif group, there were 2 patients lost to follow-up.Thus, 54 patients in the o-tlif group and 55 in the mi-tlif group were available for the study.All patients were followed up for 4 postoperative years.Six patients in the o-tlif group experienced small dural tears intraoperatively.All these tears were repaired intraoperatively with no influence on the outcomes.

• 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: 19177427
• MDR Text Key: 341001904
• Report Number: 0009617544-2024-00046
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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): Required Intervention