MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER 2; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

This report is being filed after the review of the following journal article: kreinest m., schmahl d., grützner p.A., and matschke s.(2017), radiological results and clinical patient outcome after implantation of a hydraulic expandable vertebral body replacement following traumatic vertebral fractures in the thoracic and lumbar spine: a 3-year follow-up, spine, vol.42 (8), pages e482¿e489 (germany).The aim of this prospective monocentric study is the analysis of radiological images and the clinical outcome 3 years after implantation of a hydraulically expandable vbr following traumatic vertebral body fracture in the thoracic-lumbar spine in order to analyze the capability of the implant in patients with spinal trauma.Between september 2009 to december 2010, a total of 47 patients (26 male and 21 female) with a mean age of 46.5±17.0 years, with an indication for dorso-ventral stabilization were included in the study.All patients first underwent dorsal percutaneous instrumentation (viper 2; depuy synthes, tuttlingen, germany), then vetral stabilization was performed using a competitor device.The mean time of final follow-up was 36.9±4.1 months (range: 30.1¿48.7 months).The following complications were reported as follows: 11 patients had dorsal stabilization removal after 18 months due to muscular discomfort.2 patients had occasional restriction of movement due to back pain.1 patient had persistent back pain.1 patient had herniated lumbar disk (fracture th 12).1 patient had spinal fracture due to bicycle accident 3 years after implantation.1 patient had osteoporotic spinal fracture.1 patient had fracture c 1, intracerebral bleeding, extremity fractures due to fall 2 years after implantation.1 patient had cardiac decompensation.1 patient had prolonged wound healing (dorsal stabilization).1 patient had lipoma.This report is for a viper 2 constructs.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Brand name.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 - CONSTRUCTS: VIPER 2
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12454083
• MDR Text Key: 270847588
• Report Number: 1526439-2021-01926
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• 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