MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown rod/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between july 2014 to july 2017.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.(b)(4).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: lee, y.C.Et al (2019), minimally invasive stabilization for thoracolumbar and lumbar fractures: a comparative study with short segment open schanz screw constructs, journal of spine surgery, vol.5 (1), pages 13-18 (australia).The aim of this retrospective study is to compare radiographic and clinical indices of open schanz screw fixation to mis fixation with monoaxial-polyaxial screw constructs for thoracolumbar and lumbar fractures.Between july 2014 to july 2017, a total of 32 patients underwent short segment internal fixation.Technique used were minimally invasive surgery (mis) in 13 patients (7 male and 6 female) with a mean age of 42 years using viper 2 (depuy synthes spine, raynham, massachusetts, usa) pedicle screw instrumentation.19 patients (12 male and 7 female) with a mean age of 37 years underwent open transpedicular schanz screw-rod construct without decompression (os) using a standard pedicle screw and rod instrumentation was utilized (ao uss schanz depuy synthes, west chester, pa, usa).The mean duration of follow-up was 9.6 and 10.2 months respectively.The following complications were reported as follows: mis group: 1 patient had postoperative ileus which resolved non-operatively.On immediate postoperative erect radiographs, the mis group lost 4° of correction, equating to a 15% loss.At final follow-up, mis group had a further loss of position of 28%.At final follow-up, there was significant loss of reduction of the vertebral body in the mis group of 9.Only 2 of the 52 screws (4%) inserted we graded as grade 1b (in-out-in).Os group: 1 patient progressed to non-union and had failure of implants.On immediate postoperative erect radiographs, the os group lost 9° of correction, equating to a 55% loss.At final follow-up, os groups had a further loss of position of 96%.At final follow-up, there was significant loss of reduction of the vertebral body in the open group of 15.This report is for an unknown depuy spine viper 2.This report is for one unknown rod.This is report 2 of 2 for (b)(4).

• Brand Name: UNKNOWN RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9828653
• MDR Text Key: 193116309
• Report Number: 1526439-2020-00700
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 02/17/2020
• 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