MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - cement/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: barbagallo g., et al (2017) restoration of thoracolumbar spine stability and alignment in elderly patients using minimally invasive spine surgery (miss).A safe and feasible option in degenerative and traumatic spine diseases, acta neurochirurgica supplement 124 , pages 69-74 (italy) doi 10.1007/978-3-319-39546-3_11.This study aims to analyse the prospectively collected clinical, functional, and radiological data of elderly patients treated with miss for degenerative and traumatic thoracolumbar pathologies.A total of 45 patients (17 males and 28 females) with a mean age of 73 years (range 65¿89), suffering from degenerative spondylolisthesis (15), lumbar canal stenosis with instability and or de novo scoliosis (6), and traumatic osteoporotic vertebral fractures (24) were prospectively enrolled.In 21 patients a miss pedicle-screw fixation with mini-open transforaminal lumbar interbody fusion (m-open tlif) was performed.Of the remaining 24 patients treated with miss, 18 underwent percutaneous pedicle-screw fixation (ppsf) with or without vertebral body cement augmentation (confidence spinal cement; depuy spine,) and 6 underwent vertebroplasty or kyphoplasty.The viper percutaneous pedicle-screw fixation system with fenestrated screws (depuy spine raynham, us) or the illico percutaneous fixation system (alphatec spine carlsbad, us, us) with expandable screws (osseoscrew; alphatec spine carlsbad, us) was used.Follow-up ranged from 6 to 59 months, with a mean of 28 months.The following complications were reported as follows: 2 the 45 patients developed the following postoperative complications: a case of a (b)(6)-year-old woman for surgical treatment of l2 burst fracture, previously treated elsewhere with percutaneous cement injection.X-rays performed 3 weeks after the procedure documented the pull-out of l3 screws.Replacement and augmentation of the l3 screws was performed, together with caudal extension of instrumentation.Spondylodiscitis.This report is for an unknown depuy spine confidence spinal cement.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9962969
• MDR Text Key: 196568954
• Report Number: 1526439-2020-00855
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention