MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482802640

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/06/2016

Event Type  malfunction  

Event Description

It was reported that; surgeon performed a percutaneous spinal fusion t11 to l4 on (b)(6) 2016 to treat an l2 burst fracture.On follow up visit, 11/30/17, an x-ray revealed what appears to be a broken screw at right l4.No remediation was performed.Surgeon informed representative weeks later.

Manufacturer Narrative

Device history review, complaint history review and device evaluation could not be performed since the device was not returned and lot# was not provided.According to surgical technique, while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.The device was implanted for approximately 13 months.It is likely that the screw fractured due to instantaneous load over time leading to material fatigue.

Event Description

It was reported that; surgeon performed a percutaneous spinal fusion t11 to l4 on (b)(6)2016 to treat an l2 burst fracture.On follow up visit, 11/30/2017, an x-ray revealed what appears to be a broken screw at right l4.No remediation was performed.Surgeon informed representative weeks later.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7150879
• MDR Text Key: 96020738
• Report Number: 0009617544-2017-00448
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 07613327001938
• UDI-Public: (01)07613327001938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482802640
• Device Catalogue Number: 482802640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• 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 Age: 53 YR
• Patient Weight: 62