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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: SYNFIX EVOLUTION; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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SYNTHES GMBH UNK - CONSTRUCTS: SYNFIX EVOLUTION; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Non-union Bone Fracture (2369); Osteolysis (2377); Impaired Healing (2378); Decreased Sensitivity (2683); Unspecified Nervous System Problem (4426); Joint Laxity (4526); 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.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 constructs: synfix evolution/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: 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
Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) from a european spine tango registry between october 05, 2017 and october 05, 2022, with a total of 40 patients (23 males, 17 females, mean age 55.9 years) who were operated with synfix evolution implants.The following complications have been identified: intraoperative complications: 1 patient had dural lesion.1 patient had vascular injury.Postoperative complication: 2 patients had pulmonary complications.2 patients had sensory dysfunction.1 patient had motor dysfunction reoperations: 1 patient had reoperation due to adjacent segment pathology.1 patient had reoperation due to failure to reach therapeutic goals.2 patients had reoperation due to hardware removal.2 patients had reoperation due to implant failure.1 patient had reoperation due to instability.1 patient had reoperation due to non-union.1 patient had reoperation due to spinal imbalance.1 patient had reoperation due to an unknown reason.This is for unknown depuy spine synfix evolution implants.This is report 1 of 1 for (b)(4).
 
Event Description
This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) from a european spine tango registry between may 10, 2017 and december 12, 2023, with a total of 82 patients (44 males, 38 females, mean age 52.1 years) who were operated with synfix evolution implants.The following complications have been identified: intraoperative complications: 2 patients had dural lesion.Postoperative complication before discharge: 2 patients had pulmonary complications.Postoperative complication at less than 28 days follow-up: 1 patient had sensory dysfunction.1 patient had other complication.Reasons for reoperations at postoperative follow-up: 2 patients had reoperation due to hardware removal.2 patients had reoperation due to non-union.1 patient had reoperation due to instability.1 patient had reoperation due to failure to reach therapeutic goals.2 patients had reoperation due to implant failure.2 patients had reoperation due to adjacent segment pathology.1 patient had reoperation due to spinal imbalance.1 patient had reoperation due to implant malposition.1 patient had reoperation due to wound healing problem.5 patients had reoperation due to an unknown reason.This is for unknown depuy spine synfix evolution implants.This is report 1 of 3 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.H10 additional narrative: b5 h6: 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.E1.
 
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Brand Name
UNK - CONSTRUCTS: SYNFIX EVOLUTION
Type of Device
ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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 Key15543316
MDR Text Key301178792
Report Number8030965-2022-07878
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2022
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? No
Date Manufacturer Received04/10/2024
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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