• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - MONO/POLYAXIAL SCREWS: VIPER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDOS INTERNATIONAL SàRL CH UNK - MONO/POLYAXIAL SCREWS: VIPER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Migration (4003)
Patient Problems Fatigue (1849); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown mono/polyaxial screws/unknown lot. Part and lot numbers 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. 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: wang, m. Y. (2013), improvement of sagittal balance and lumbar lordosis following less invasive adult spinal deformity surgery with expandable cages and percutaneous instrumentation, journal of neurosurgery: spine, vol. 18 (xx), pages 4-12 (usa). The aim of this study is to describe the evolution of an mis method for treating asd with attention to sagittal correction. During an 18-month period, a total of 25 patients (8 male and 17 female; mean age of 72 years) were treated surgically. Surgery was performed using viper (depuy spine) together with competitor devices. The minimum follow-up period after surgery was 12 months. The following complications were reported as follows: 3 patients had worsening of coronal balance due to straightening of the major curve without addressing the fractional curve adequately. In 2 of these patient¿s coronal balance worsened from 1 cm to 3 cm, and in another patient it worsened from 2 cm to 3 cm. 1 patient experienced neurological worsening which involved new dorsiflexor weakness of the foot. In 1 patient with preoperative nerve root pain, there is no resolution of leg pain. 1 patient had a prolonged hospitalization course due to severe constipation. In 3/25 patients (3 of 52 treated levels) in which fusion could not be verified, this occurred at the thoracolumbar junction where no interbody fusion was performed. In 1 case there was some evidence of screw loosening and in the other 2 levels, there was a paucity of bony growth in the posterolateral or interlaminar space. However, these patients did not experience any local symptoms of pseudarthrosis as of the last follow-up. 2 patients had a medial l-5 screw breach. In 1 case the screw was removed 2 weeks after the index surgery due to foot weakness. In the other case, the patient only had numbness and the screw was removed after confirmation of solid bony fusion 9 months after surgery. 1 patient had an asymptomatic grade ii screw breach at t-10. 1 patient had an early screw pullout at s-1 and the screw was removed 1 year later after confirmation of successful l5¿s1 fusion. A (b)(6) year-old woman who did not suffer permanent myocardial ischemia had acute coronary syndrome. This report is for an unknown depuy spine viper constructs and unknown depuy spine viper mono/polyaxial screws.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - MONO/POLYAXIAL SCREWS: VIPER
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key12454407
MDR Text Key271687060
Report Number1526439-2021-01933
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
-
-