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 Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: li j et al (2018), selective fusion in lenke 5 adolescent idiopathic scoliosis, world neurosurgery, volume 118, pages e784-e791 (china).This study aims to compare the radiographic and clinical outcomes between patients with lenke 5 ais who underwent asf with structural cages and those who underwent psf, with a minimum 5-year follow-up time.A total of 77 patients with lenke 5 ais were included in this study.These patients were divided into two groups asf group and the psf group.A total of 40 patients (5 males and 35 females) age at surgery 14.80 - 2.1 underwent anterior selective fusion.The specific instrumentation used in asf included isola (depuy spine, raynham, massachusetts, usa) in 8 patients.While 37 patients (4 males and 33 females) age at surgery 14.7 - 2.2 underwent posterior selective fusion.Posterior fusion was performed with a pedicle screw-rod construct.The specific screw-rod instrumentation systems included in psf were the expedium system (depuy spine) in 6 patients.The mean follow-up time was 93.9 - 21.4 months (range, 60-144 months) in the asf group and 80.4 - 15.2 months (range, 60-108 months) in the psf group.The following complications were reported as follows: asf group: instrument-related complications, 3 patients had pseudoarthrosis, 2 patients had an adding-on phenomenon, 1 patient had pjk.At 3 months postoperatively, 1.4- 10.8 and 2.3 - 8.1 increases of lordosis in isa were created in the asf and psf groups.1 patient had rod breakage at the 5-year follow up.Psf group: instrument-related complications, 1 patient had adding-on phenomenon, 5 patients had pjk.At 3 months postoperatively, 1.4- 10.8 and 2.3 - 8.1 increases of lordosis in isa were created in the asf and psf groups.This is report 1 of 3 for (b)(4).This report is for an unknown isola and expedium system (screw/rod construct).

• 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9519358
• MDR Text Key: 189097146
• Report Number: 1526439-2019-52766
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• 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