MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH; SURGICAL MESH

Device Problem Migration (4003)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown syn-mesh/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: michael d.Daubs (2005), early failures following cervical corpectomy reconstruction with titanium mesh cages and anterior plating, spine vol.30 (n12), pages 1402-1406 (usa).Doi: 10.1097/01.Brs.0000166526.78058.3c.The aim of this retrospective study is to evaluate the use of titanium mesh cages in the reconstruction of the cervical spine following corpectomy.A total of 23 patients (13 males and 10 females) with a mean age of 61 years (range, 32 to 84 years) were included in the study.These patients underwent anterior cervical corpectomy reconstructed with a titanium mesh cage, local autograft, and fixed anterior plating.Harms cages were used in 22 patients and syn-mesh in 1 patient.All cases were stabilized with a fixed anterior cervical plate.A synthes cervical spine locking plate (cslp) was used in 22 patients and a depuy peak plate in 1 patient.The mean duration of follow-up was 28 months.The article did not specify which of the devices were being used to capture the following complications: a (b)(6)-year-old female patient had a catastrophic failure of fixation with cage subsidence and distal plate extrusion after 8 weeks postoperatively.A (b)(6)-year-old female patient had a catastrophic failure of fixation with cage subsidence and distal plate extrusion after 4 weeks postoperatively.A (b)(6)-year-old male patient had a catastrophic failure of fixation with cage subsidence and distal plate extrusion after 2 weeks postoperatively.A (b)(6)-year-old female patient had a catastrophic failure of fixation with cage subsidence and distal plate extrusion after 3 weeks postoperatively.An (b)(6)-year-old male patient had a catastrophic failure of fixation with cage subsidence and distal plate extrusion after 5 weeks postoperatively.A (b)(6)-year-old male patient had a failure reconstruction after 7 weeks postoperatively.1 patient had fixation failure in the 1-level corpectomy group.4 patients had fixation failure in the 2-level group.2 patients had fixation failure in the 3-level group.1 patient with a postoperative hematoma requiring surgical evacuation.2 patients with severe dysphagia.1 patient requiring the temporary placement of a gastric feeding tube.1 patient with a c-5 nerve palsy that fully recovered at 6 months after surgery.1 patient died 3 months following revision surgery of myocardial infarct.This report is for an unknown synthes syn-mesh.This is report 4 of 9 for (b)(4).

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8996432
• MDR Text Key: 161795509
• Report Number: 2939274-2019-60464
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR