MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Injury (2348); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown spine carbon fiber cage/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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

This report is being filed after the review of the following journal article: lykissas, m.G.Et al.(2014), paresis of the l5 nerve root after reduction of low-grade lumbosacral dysplastic spondylolisthesis: a case report, journal of pediatric orthopaedics b, vol.23, pages 461-466 (usa).This study presents a case report of a (b)(6) year old female patient who presented a 6-month history of bilateral lower extremity pain in her posterior thighs occurring with walking and standing.Radiographs of her lumbar spine showed grade 2 spondylolisthesis of l5 on s1, a dome-shaped sacrum, focal kyphotic deformity at the lumbosacral junction (a slip angle of 10°), and a mild right lumbar curve on the coronal plane.Mri revealed a severe central canal, a subarticular lateral recess, and bilateral, foraminal stenosis at the l5¿s1 level, moderate to severe central canal stenosis at the l4¿l5 level, and disk degeneration with disk bulge at the l5¿s1 level.A computed tomography scan confirmed the radiographic findings and further demonstrated posterior spur formation on the inferior posterior aspect of l5.The patient underwent decompression surgery using a lordotic carbon fiber cage (concorde; depuy spine inc., raynham, massachusetts, usa.).Postoperative imaging revealed mild left l5¿s1 neural foraminal narrowing due to osseous encroachment by remodeling of the inferior posterior aspect of the l5 vertebra and accurate positioning of the interbody cage and screws at all levels.At the last follow-up 12 months after surgery, the patient had partial recovery, with grade 4 muscle function of the left extensor hallucis longus and tibialis anterior muscles.This report is for an unknown spine carbon fiber cage.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 10871422
• MDR Text Key: 218521285
• Report Number: 1526439-2020-02252
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• 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
• Patient Age: 16 YR