MAUDE Adverse Event Report: SYNTHES GMBH UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH; SURGICAL MESH

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from synthes reports an event in south korea as follows: this report is being filed after the review of the following journal article shin, w.K.Et al (2022), mechanical failure after total en bloc spondylectomy and salvage surgery, neurospine, vol.19 (01) pages 146-154 (south korea).The aim of the study was to present the incidence and case of mechanical failure and to suggest strategies for salvage surgery.Between july 2011 to april 2018, a total of 19 consecutive patients (9 with primary tumors, 10 with metastatic tumors) underwent total en bloc spondylectomy (tes) for primary or metastatic tumors.A posterior approach was used for 15 thoracic tumors, and a combined anterior and posterior approach was used for lumbar tumors.A titanium-based mesh-type interbody spacer (synmesh system, depuy synthes, ma, usa) filled with autologous and cadaveric bone was used for anterior support, and a pedicle screw/rod system (expedium, depuy synthes, raynham, ma, usa; legacy, non-synthes product) was used for posterior support.For 1-level tes, the fixation points were 2 levels above and below, and for 2-level tes, they were 3 levels above and below.In the first surgical procedure, a single titanium-based 5.5-mm diameter rod was used on each side.After fixation with the cage and rod/screws, the posterior structure was reconstructed to reduce compression by soft tissue and the formation of compressive scar tissue on the spinal cord.Patients were followed-up for 59±38 months (range, 11¿133 months).The following complications were reported as follows: two patients developed chylothorax, which was controlled with a chest tube and a lipid-free diet for 1 week.7 nonunion.A 23-year-old man presented with back pain and was diagnosed with gct at t6 and t7.The vertebral column was reconstructed using a mesh-type titanium cage filled with autologous and cadaveric bone, pedicle screws, a rod system, and a rectangular tailored cadaveric femoral head between laminae.Although the tumor did not recur, a unilateral rod fracture occurred 1.5 years after tes (fig.3i), and the ct scan showed no solid bony union between the cage and t8 (fig.3j).Because patients did not complain of pain, the fracture was closely observed, but bilateral rod breakage occurred 6 months later (2 years after tes) (fig.3k).Because the ventral approach and additional anterior support seemed to be risky, the fractured rods were replaced with cobalt-chromium-based rods, and additional rods were applied (fig.3l).Images were taken 1 year later (37 months after tes) showed no further rod breakage or cage subsidence (mechanical failure) at either the anterior or posterior spinal columns.The patient had no further mechanical problems until back pain reappeared at 69 months after tes, and radiation-induced osteosarcoma was diagnosed.Because the mass was extensive and not operable, chemotherapy was performed.Finally, the patient died 13 months later (72 months after tes).This complaint is related to pc-001254679, which reports the depuy spine products involved.This report involves one unk - vert body replace - mesh: synmesh.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown vert body replace - mesh: synmesh/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility address: (b)(6) korea.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.

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16051650
• MDR Text Key: 306174660
• Report Number: 8030965-2022-11527
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• 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