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

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: viezens, l.Et al (2018), safety and efficacy of single-stage versus 2-stage spinal fusion via posterior instrumentation and anterior thoracoscopy: a retrospective matched-pair cohort study with 247 consecutive patients, world neurosurgery, vol.109, pages e739-e747 (germany).The aim of this retrospective, single-center study is to determine the optimal timing of dorsal osteosynthesis and thoracoscopy in terms of perioperative morbidity and safety.Between february 2006 to march 2013, a total of 247 patients (126 males and 121 females) were included in the study.Surgery was performed using synex (depuy synthes, zuchwil, switzerland), synmesh-cage (depuy synthes), or other competitor¿s devices.The follow-up period was 3 months postoperatively and once a year thereafter.The following complications were reported as follows: 6 patients died.13 patients had pneumonia.10 patients had urinary tract infection.4 patients had gastritis or enteritis.4 patients had transitory psychotic syndrome.2 patients had sepsis.2 patients had non-st-segment elevation myocardial infarction.11 patients had non-surgery-related complications during perioperative period, not classified.17 patients need to be converted to thoracotomy.The observed complications in the perioperative period included screw misplacement, wound healing disorders, pneumothorax that required therapy, and implant failure.25 patients had wound complications, pneumothorax, and implant misplacement.38 patients had wound complications, hematoma, and implant misplacement.47 patients had complications related to anterior or posterior surgery.This report is for an unknown synthes synmesh.It captures the reported events of wound complications (wound healing delayed, infection) and surgical intervention.This is report 2 of 4 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - MESH: SYNMESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8883801
• MDR Text Key: 154112736
• Report Number: 8030965-2019-67116
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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: 07/16/2019
• 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