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

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).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 12316928
• MDR Text Key: 266668677
• Report Number: 1526439-2021-01676
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• 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 Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• 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