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 Hematoma (1884); Nerve Damage (1979); Perforation of Vessels (2135); Speech Disorder (4415); Unspecified Tissue Injury (4559)

Event Type  Injury  

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 (b)(6) 2006, and (b)(6) 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 (b)(6), why decision was taken to analyze the whole sample.Mean age of the patients was (b)(6).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 2 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: (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 a (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.

• 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 Key: 12740002
• MDR Text Key: 285061287
• Report Number: 8030965-2021-09232
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• 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 Received: 11/02/2021
• 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 Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention