MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: VIPER 2; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: archavlis e., amr n., kantelhardt s.R., giese a., (2018) rates of upper facet joint violation in minimally invasive percutaneous and open instrumentation: a comparative cohort study of different insertion techniques, j neurol surg a volume 79, no.A1, pages 1¿8 (germany).This retrospective cohort study aims to compare the rate of superior facet joint violation with the use of percutaneous robot-assisted screw insertions versus percutaneous fluoroscopy-guided screws versus screws placed through a standard conventional open midline approach by a single surgeon who changed the technique gradually over time.Between january 2012 and january 2016.A total of 286 patients received single level lumbar instrumentation, fusion, and decompression for degenerative spondylolisthetic stenosis grades i and ii and degenerative disease.194 patients met the inclusion criteria and were divided into three groups according to the method of instrumentation.From january 2015 to january 2016, 58 patients (22 males and 36 females) age 51 - 12 years underwent a percutaneous robot-assisted instrumentation (group 1).These cases involved placement of guiding k-wire for percutaneous screw implantation, using a spinal guidance robot (renaissance, mazor robotics, caesarea, israel).The pedicle screw system used was viper2 (depuy synthes orthopaedie gmbh, kirkel, germany).Whereas from january 2013 to december 2014, 64 patients (30 males and 34 females) age 53 -11 years were treated with percutaneous transpedicular instrumentation using fluoroscopic guidance (group 2).The pedicle screw system used in this group was matrixmis (depuy synthes orthopaedie).Between 2010 and 2012, prior to the introduction of minimally invasive techniques by the first author, 72 consecutive patients (32 males and 40 females) age 49-13 years received a conventional open midline procedure with pedicle screw insertion (group 3) with a competitor¿s device.The following complications were reported: two of the 116 screws in the robotic group showed a grade iii violation of the facet joint; where screw heads violate the articular surface.One of the 116 screws in the robotic group showed a grade ii violation of the facet joint; where screw threads interposed between superior and inferior articular process.This report is for unknown depuy spine viper2.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: there are multiple patients.All known information is provided in the literature article.510k: this report is for an unknown viper2 screw/unknown lot.Part and lot number are unknown; udi 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.(b)(4).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 - SCREWS: VIPER 2
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 14961071
• MDR Text Key: 295599711
• Report Number: 1526439-2022-01000
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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?: Yes
• Date Manufacturer Received: 06/10/2022
• 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