MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kim, y.Et al.(2005), proximal junctional kyphosis in adolescent idiopathic scoliosis following segmental posterior spinal instrumentation and fusion, spine, vol.30, number 18, pages 2045-2050 (usa).The purpose of this study is to analyze the long-term proximal junctional change in adolescent idiopathic scoliosis (ais) following segmental posterior spinal instrumentation and fusion 5 years or more after surgery.A total of 193 patients (27 males and 166 females) with an average age of 14.3 years (range, 10.8¿19.4 years) underwent segmental posterior spinal instrumentation and fusion using a 5.0-mm moss-miami (depuy acromed, raynham, ma) instrumentation.There was a 5-year minimum follow-up (average, 7.3 years; range, 5¿16.7 years).The following complications were reported as follows: a (b)(6) year old female patient had a 51% correction rate.50 patients had proximal junctional kyphosis (7.3 years postoperation).Among them, 41 patients demonstrated pjk at 2-year postoperation.9 patients who did not show pjk at 2-year postoperation demonstrated pjk at final follow-up between 10 degrees and 14 degrees.Patients who shows pjk demonstrated significant anterior displacement of the c5 sagittal plumb.This report is for a 5.0-mm moss-miami (depuy acromed, raynham, ma) instrumentation.This complaint involves two (2) device.This is 2 of 2 for report (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• 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: 9565857
• MDR Text Key: 189438847
• Report Number: 1526439-2020-00297
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• 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: 12/12/2019
• 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