MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: FENESTRATED SCREW SYSTEM; SCREW, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Sepsis (2067); Spinal Cord Injury (2432); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screws: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: massaad, e.Et al.(2021), safety and efficacy of cement augmentation with fenestrated pedicle screws for tumor-related spinal instability, neurosurgery focus, vol.50, pages 1-10 (usa).This study aimed to assess the safety and efficacy of cement augmentation with fenestrated pedicle screws in patients undergoing posterior, open thoracolumbar surgery for spinal metastases.From 2016 to 2019, 69 patients underwent open posterior surgery with a total of 502 cement-augmented screws (mean 7.8 screws per construct).Implants used were fda approved fenestrated screw systems (depuy synthes and medtronic).The mean age at the time of surgery was 64.7 ± 10.3 years (median age [range] 67 [30¿84] years), and there were 38 males and 31 females.The median follow-up period for those who survived past 90 days was 25.3 months.The following complications were reported as follows: 9 patients died within 90 days.5 patients had urinary tract infections.5 patients had wound infection/dehiscence.They had wound revision (w/in 30 days of op).3 patients had deep venous thrombosis/pulmonary embolism.2 patients had delirium.2 patients had fever of unknown origin.1 patient had acute renal failure.1 patient had atrial fibrillation.1 patient had ileus.1 patient had pleural effusion.1 patient had pneumonia.1 patient had sepsis.2 patients had disease progression (>90 days postop) which required reoperation.1 patient had asymptomatic pulmonary cement embolism.On postoperative ct.The patient was observed and did not develop any adverse sequelae to this finding or require anticoagulation.1 patient continued to have refractory axial back pain 2 years after surgery without ct evidence of instrumentation failure or lucency around the screws which required additional spine surgery.The instrumentation was removed after lack of treatment response to palliative pain therapies.2 patients underwent additional surgery for extension of instrumentation for adjacent-level disease progression and cord compression.Follow-up ct imaging did not show any evidence of instrumentation failure, screw loosening, rod or screw fracture, or screw pullout.This report is for an unknown synthes fenestrated screw systems.This report is for (1) unk - screws: spine-us.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CONSTRUCTS: FENESTRATED SCREW SYSTEM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12522570
• MDR Text Key: 273134838
• Report Number: 2939274-2021-05725
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention