MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - unk - constructs: expedium lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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

Device report from synthes reports an event in united kingdom as follows: this report is being filed after the review of the following journal article: tahir m, et al.(2022), a comparison of the post-fusion outcome of patients with early-onset scoliosis treated with traditional and magnetically controlled growing rods, bone joint j, volume 104-b (2), pages 257¿264 (united kingdom).The aim of this study was to compare the clinical and radiological outcomes of patients with early-onset scoliosis (eos), who had undergone spinal fusion after distraction-based spinal growth modulation using either traditional growing rods (tgrs) or magnetically controlled growing rods (mcgrs).Between 2008 and 2019, 43 patients with early-onset scoliosis who underwent implantation of either traditional growing rods or magnetically controlled growing rods were included in the study.There were 16 males and 27 females with a mean age of 6.4 years (sd 2.6; 3 to 13) at the time of the initial implantation procedure and 12.2 years (sd 2.2; 7 to 18) at final fusion.A total of 16 patients were treated with mcgrs and 27 with tgrs.In the mcgr group, the patients were treated with a competitor¿s device.In the tgr group, the patients were treated with either the unknown depuy spine paediatric isola or the unknown depuy spine paediatric expedium implants.Lengthening was carried out at roughly six-month intervals in the tgr group, through a small posterior midline incision over the longitudinal connectors.After fusion, patients in the tgr group had a mean follow-up of three years (sd 1.8; 0.2 to 7.1) compared to 1.4 years (sd 1.0; 0.2 to 3.9) in the mcgr group.Complications were reported as follows: 8 patients had unplanned revision due to rod fractures.7 patients had infection.3 of whom had infected metalwork which needed to be removed.All three were successfully managed with reimplantation of the traditional growing rods after a period of antibiotic treatment.6 patients developed a proximal junctional kyphosis.2 of whom required earlier fusion or extension of the instrumentation into the cervical spine.The rest were managed without any additional surgical intervention during the study period.This report is for the unknown depuy spine paediatric isola and the unknown depuy spine paediatric expedium spinal system.This is report 4 of 4 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 14695543
• MDR Text Key: 294020163
• Report Number: 1526439-2022-00848
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention