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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown viper system/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.
 
Event Description
This report is being filed after the review of the following journal article: wu, j. Et al. (2021), posterior fixation can further improve the segmental alignment of lumbar degenerative spondylolisthesis with oblique lumbar interbody fusion, bmc musculoskeletal disorders, vol. 22, no. 218, pages 1-9 (china). The aim of this study was to compare changes of the radiographical segmental alignment following stand-alone cage insertion and additional posterior fixation in the same procedure setting of olif for patients with degenerative spondylolisthesis. From july 2017 to august 2019, a total of 33 patients (6 males and 27 females with an average age of 66. 9 ± 8. 7 years) underwent oblique lumbar interbody fusion (olif) procedure using a viper mis spine system, depuy spine. Twenty-one patients underwent one-level fusion, 9 two-level fusion and 3 multi-level (
=
three levels) fusion. All these selected patients have mid-term follow-up (postoperative 1 year) with intact pain and disability scores. The following complications were reported: 4 patients complained transient weakness of hip flexion and numbness over the anterior thigh which disappeared within 3 months. 6 patients complained of residual neurological deficit which was not relieved at postoperative 1 year. This report is for an unknown depuy spine viper system. This is report 1 of 1 for (b)(4).
 
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Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 
SZ  
6103142063
MDR Report Key12316928
MDR Text Key266668677
Report Number1526439-2021-01676
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received07/14/2021
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: 08/12/2021 Patient Sequence Number: 1
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