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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH; SURGICAL MESH
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SYNTHES GMBH UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH; SURGICAL MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Dysphagia/ Odynophagia (1815); Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Post Operative Wound Infection (2446); Speech Disorder (4415); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: this report is for an unk - vertebral body replacement 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.Reporter is (b)(6).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: the current report is a retrospective analysis of 93 patients (52 female) who underwent instrumentation skyline between january 02, 2006, and november 22, 2020.In 3 cases it was combined with synapse posterior.71 cases were combined with an intracorporal cage, of which there are 1 concorde, 1 synmesh, 1 confidence cement and 68 non-depuy brands.Exclusion of non-depuy brands would reduce the sample to less than 25%, why decision was taken to analyze the whole sample.Mean age of the patients was 54 years.Intra-operative complications: 1 dural tear.1 recurrent nerve injury.Post-op complications within 1 year: 14 dysphagia.11 recurrent nerve injury.1 ssi superficial readmissions: 2 drain hematoma.2 redecompression.1 revision of fusion.Global assessment of neck pain (ga) failure %: fu 1 yrs.:37 fu 2 yrs.:36.Global assessment of arm pain (ga) failure % : fu 1 yrs.: 44 fu 2 yrs.: 52.This is for depuy synthes synmesh and synapse posterior.This report is for one (1) unk - vertebral body replacement - mesh: synmesh.This is report 4 of 4 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).This report is for an unk - vertebral body replacement 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.Reporter is (b)(6).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: the current report is a retrospective analysis of 93 patients (52 female) who underwent instrumentation skyline between january 02, 2006, and november 22, 2020.In 3 cases it was combined with synapse posterior.71 cases were combined with an intracorporal cage, of which there are 1 concorde, 1 synmesh, 1 confidence cement and 68 non-depuy brands.Exclusion of non-depuy brands would reduce the sample to less than 25%, why decision was taken to analyze the whole sample.Mean age of the patients was 54 years.Intra-operative complications: 1 dural tear.1 recurrent nerve injury.Post-op complications within 1 year: 14 dysphagia.11 recurrent nerve injury.1 ssi superficial readmissions: 2 drain hematoma.2 redecompression.1 revision of fusion.Global assessment of neck pain (ga) failure %: fu 1 yrs.:37 fu 2 yrs.:36.Global assessment of arm pain (ga) failure % : fu 1 yrs.: 44 fu 2 yrs.: 52.This is for depuy synthes synmesh and synapse posterior.This report is for one (1) 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.Additional narrative: 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
The current report is a retrospective analysis of 391 patients (377 females, mean age 52 years) who underwent instrumentation skyline between 2013 and december 31, 2023.In 7 cases it was combined with synapse posterior.439 cases were combined with an intercorporal cage, of which there are 1 concorde, 2 cervios cage, 3 conduit tlif, 6 synmesh, 1 confidence cement, 88 conduit cervical, 67 syncage and 271 non-depuy brands.The conduit cervical (cc) cages in this cohort are part of a total of 210 cc cages of interest to analyze separately, so they will be excluded here.This leaves 391 cases for analysis.Complications were reported as follows: intra-operative complications: 3 patients had dural injury.1 patient had vocal cord dysfunction.2 patients had blood vessel injury.1 patient had hematoma.1 patient had esophagus injury.1 patient death.Post-op complications within 1 year: 85 patients had dysphagia.59 patients had vocal cord dysfunction.7 patients had surgical site infection.1 patient had pulmonary embolism.1 patient had thrombosis.Reasons for reoperations: 5 patients had hematoma drain.5 patients had redecompression.1 patient had revision of fusion.1 patient had drain of infection.1 patient had repair of dural injury.1 patient had reoperation due to other reasons.1 patient had 2nd reoperation to drain infection.This report is for unknown synthes synmesh this report captures the following adverse events: post-op complications within 1 year: 85 patients had dysphagia.59 patients had vocal cord dysfunction.7 patients had surgical site infection.1 patient had pulmonary embolism.1 patient had thrombosis.Reasons for reoperations: 5 patients had hematoma drain.5 patients had redecompression.1 patient had revision of fusion.1 patient had drain of infection.1 patient had repair of dural injury.1 patient had reoperation due to other reasons.1 patient had 2nd reoperation to drain infection.
 
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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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12740005
MDR Text Key285220900
Report Number8030965-2021-09235
Device Sequence Number1
Product Code EZX
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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