MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Injury (2348)

Event Date 02/03/2018

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: mohanty s.P., kanhangad m., bhat s.N., chawla s., (2018) morphometry of the lower thoracic and lumbar pedicles and its relevance in pedicle fixation, musculoskeletal surgery volume 102, pages 299¿305(india).This study aims to assess the morphology of the lower thoracic and lumbar pedicles based on computerized tomographic (ct) scans in indian patients.Between august 2009 and august 2014, 135 consecutive adult patients treated for thoracolumbar and lumbar spinal injuries were included in the study.Of the 135 patients included in the study, 117 were treated by internal fixation of the spine using the moss-miami transpedicular screw system.In the lower thoracic spine, screws of 5 mm diameter and 30 mm length were used, while screws of 6 mm diameter and 35 mm length were inserted in the lumbar spine.The patients were followed up for a minimum period of 2 years.The following complications were reported as follows: forty-one screws breached the pedicle wall.Nine screws penetrated the lateral pedicle cortex.32 screws penetrated the medial pedicle cortex.This report is for an unknown moss-miami transpedicular screw system.This complaint involves ten (10) devices.This is 2 of 10 for report (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9557159
• MDR Text Key: 177245511
• Report Number: 1526439-2020-00187
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• 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: 12/11/2019
• 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