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 08/28/2020

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

The article 'accuracy of fluoroscopic guidance with the coaxial view of the pedicle for percutaneous insertion of lumbar pedicle screws and risk factors for pedicle breach' in journal of neurosurgery: spine, august 28, 2020, was reviewed.In this study the authors aimed to evaluate the rate of malposition, including pedicle breach and superior facet violation, after percutaneous insertion of pedicle screws using the coaxial fluoroscopic view of the pedicle, and to assess the risk factors for pedicle breach.In total, 394 percutaneous screws placed in 85 patients using the coaxial fluoroscopic view of the pedicle between january 2014 and september 2017 were assessed, and 445 pedicle screws inserted in 116 patients using conventional open procedures were used for reference.Four percutaneous systems were used: es2, solera longitude (medtronic), solera voyager (medtronic), and precept (nuvasive).The pedicle screw was conventionally inserted using the midline open approach or the wiltse paraspinal approach.In all the conventional open procedures, screws were inserted before decompression and interbody implant placement; xia, arsenal (alphatec), and solera (medtronic) systems were used.Superior facet violation was evaluated as follows: grade 0, screw placement clearly outside the boundaries of the facet joint capsule; grade 1, pedicle screw abutting the facet joint capsule and superior articular process but not violating the facet joint articular surface; and grade 2, pedicle screw clearly violating any part of the articular surface of the facet joint.The accuracy of the percutaneous screw placement into the pedicle walls was classified as follows: grade 0, completely within the pedicle; grade 1, pedicle breach <2 mm; grade 2, pedicle breach of 2¿4 mm, and grade 3, pedicle breach > 4 mm.Two of the 394 screws inserted percutaneously showed a grade 2 violation, whereas 3 and 5 screws out of the 445 screws inserted conventionally showed grade 1 and 2 violations, respectively.All violations of the articular surface were small, and no revision was required.These screws did not cause neurological deficits, abnormal pain, or revision.

• 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: 19215928
• MDR Text Key: 341423508
• Report Number: 0009617544-2024-00058
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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): Other