MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: VIPER 2 MIS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK - SCREW/ROD CONSTRUCT ACCE

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

Patient Problem Spinal Cord Injury (2432)

Event Date 05/10/2022

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 unk - screw/rod construct accessories: viper 2 mis 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.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 austria as follows: this report is being filed after the review of the following journal article: hartmann, s.Et al (2022), minimally invasive versus open transforaminal lumbar interbody fusion: a prospective, controlled observational study of short-term outcome, research square, vol.Xx (xx), pages 1-17 (austria).This prospective, controlled observational, non-randomized cohort study was conducted in order to detect differences between both o-tlif and mis-tlif techniques in the short-term follow-up.During the study period, a total of 38 patients (age between 18¿99 years) who were treated with a lumbar fusion surgery were included in the study.Among these, 23 patients were treated with a one- or two level open tlif procedure (group o) and the remaining 15 patients were treated with a minimally invasive tlif procedure (group mis).The mis-tlif was performed using an expandable retractor system (pipeline; depuy synthes spine, pennsylvania, usa), pedicle screw and rod placement (viper® 2 mis spine system; depuy synthes spine, pennsylvania, usa), and an oblique cage system (concorde® interbody system; depuy synthes spine, pennsylvania, usa).The mean follow-up period was unknown.The following complications were reported as follows: mis-tlif group: 1 patient had accidental durotomy.This report is for an unknown depuy spine pipeline, viper 2 mis, and concorde cage.This is report 2 of 3 for complaint.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: VIPER 2 MIS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15776407
• MDR Text Key: 303541152
• Report Number: 1526439-2022-01949
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREW/ROD CONSTRUCT ACCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• 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