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 Problems Failure of Implant (1924); Nerve Damage (1979); Osteolysis (2377); Post Operative Wound Infection (2446); Thromboembolism (2654); Decreased Sensitivity (2683); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Type  Injury  

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 related research activity database (ddra) to compare usage and outcomes recorded in 36 patients, 36 procedures, (18 males, 18 females; mean age 58.6) for synmesh implants against all other surgical cases recorded within the spine tango registry between (b)(6) 2007 and (b)(6) 2022.Final registry report outcome description: postoperative general complications: (n=1) cardiovascular, (n=1) kidney / urinary, (n=1) thromboembolism, (n=1) other.Intraoperative surgical complications: (n=2) nerve root damage, (n=3) dural lesion.Postoperative surgical complications: (n=1) sensory dysfunction, (n=2) wound infection deep, (n=1) adjac.Segment pathology, (n=1) implant malposition, (n=1) implant failure.Reoperations: (n=5) any level, (n=2) adjacent level, (n=1) same level.This is for synthes spine synmesh implant.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.510k: this report is for an unknown vert body replace - mesh: synmesh/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.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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 36 patients, 36 procedures, (18 males, 18 females; mean age 58.6) for synmesh implants against all other surgical cases recorded within the spine tango registry between (b)(6)2007 and (b)(6)2022.Final registry report outcome description: intraoperative general complications: (n=5) not documented.Postoperative general complications: (n=1) cardiovascular.(n=2) pulmonary.(n=1) kidney / urinary.(n=1) thromboembolism.(n=1) other.Intraoperative surgical complications: (n=2) nerve root damage.(n=4) dural lesion.(n=1) other.(n=5) not documented.Postoperative surgical complications: (n=1) sensory dysfunction.(n=2) wound infection deep.(n=1) adjac.Segment pathology.(n=1) implant malposition.(n=3) implant failure.(n=1) gastrointestinal.(n=2) other.(n=25) not documented.Reoperations: (n=9) any level.(n=5) adjacent level.(n=2) same level.This is for synthes spine synmesh implant:.

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: event description updated.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: 15542987
• MDR Text Key: 301172572
• Report Number: 8030965-2022-07871
• 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: 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 Received: 10/05/2022
• 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 Received: 04/19/2023
• 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
• Patient Outcome(s): Required Intervention