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

Catalog Number UNK - VERT BODY REPLACE - MESH

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

Patient Problems Wound Dehiscence (1154); Pulmonary Embolism (1498); Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Unspecified Infection (1930); Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369); Osteolysis (2377); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Type  Injury  

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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown vertebral body replacement - mesh: synmesh/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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

Device report from synthes reports an event in click or tap here to enter text.As follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing: a real-world analysis to evaluate the clinical outcomes of patients requiring anterior reconstruction of the cervical, thoracic, or lumbar spine with the synmesh cage.Analysis years were from 2017 ¿ 2020.Adverse events were as follows: 34 incidences of neurological defict.8 instances of infection.8 instances of loss of fixation.8 instances of nonunion.6 instances of cardiovascular complication.4 instances of proximal junctional kyphosis.3 incidences of wound dehiscence.2 instances of vascular complications.2 incidences of pulmonary complications.2 incidences of adjacent compression fracture.2 incidences of adjacent segment disease.1 incidence of pulmonary embolism.1 incidence of vascular thrombosis.1 incidence of screw loosening.2 incidences of hook pull-out.1 incidence of myelopathy.1 incidence of screw breakage.1 incidence of hematoma.1 incidence of screw migration.1 incidence of csf leak.1 incidence of thrombosis.1 incidence of posterior rod fracture.1 incidence of meningeal injury.1 incidence of inadequate deformity correction.This report involves one unk - vertebral body replacement - mesh: synmesh.This is report 4 of 4 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.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

It was further reported that bilateral rod fractures documented were not depuy-synthes rods.There were two broken buried screws in l5 and s1.This is report 4 of 6 for (b)(4).

Event Description

Updated: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing: a real-world analysis to evaluate the clinical outcomes of patients requiring anterior reconstruction of the cervical, thoracic, or lumbar spine with the synmesh cage.Analysis years were from 2017 ¿ 2020.Adverse events were as follows: (b)(4) incidences of neurological deficit, two required revision (b)(4) instances of infection (b)(4) instances of loss of fixation, three required revision (b)(4) instances of nonunion, four required revision (b)(4) instances of cardiovascular complication (b)(4) instances of proximal junctional kyphosis, four required revision (b)(4) incidences of wound dehiscence (b)(4) instances of vascular complications (b)(4) incidences of pulmonary complications (b)(4) incidences of adjacent compression fracture (b)(4) incidences of adjacent segment disease (b)(4) incidence of pulmonary embolism (b)(4) incidence of vascular thrombosis (b)(4) incidence of screw loosening (b)(4) incidences of hook pull-out (b)(4) incidence of myelopathy (b)(4) incidence of screw breakage (b)(4) incidence of hematoma (b)(4) incidence of screw migration (b)(4) incidence of csf leak (b)(4) incidence of thrombosis (b)(4) incidence of posterior rod fracture (b)(4) incidence of meningeal injury (b)(4) incidence of inadequate deformity correction, one required revision.Bilateral rod fractures documented in cer were not depuy-synthes rods.There were two broken buried screws in l5 and s1.This report involves one unk - vertebral body replacement - mesh: synmesh.This is report 4 of 6 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.B5: updated event description.H6: added health effect-impact code.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 (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17059619
• MDR Text Key: 316582030
• Report Number: 8030965-2023-07055
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - VERT BODY REPLACE - MESH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• 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
• Treatment: UNK - RODS.; UNK - SCREWS: SPINE-US.; UNK - SCREWS: SPINE-US.; UNK - SCREWS: SPINE-US.
• Patient Outcome(s): Required Intervention