MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/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.

Event Description

This report is being filed after the review of the following journal article: tanida, s.Et al.(2016), vertebral endplate cyst as a predictor of nonunion after lumbar interbody fusion, spine, vool.41, number 20, pages e1216¿e1222 ((b)(6)).The aims of this study were (i) to investigate whether the formation of bone cysts after tlif using peek cages is a useful sign for predicting nonunion, as for titanium (ti) cages; and (ii) from the viewpoint of the formation of vertebral endplate cysts, to compare the bone union rate between ti and peek cages after tlif.From march 2005 to march 2011, 93 levels in 77 patients (36 males abd 41 females) were treated with ti cages.All ti cages were crescent shaped and included eight kidney bean mesh cages (medtronic sofamor danek, minneapolis,mn), one devex cage (depuy synthes spine, raynham, ma), and 84 boomerang ii cages (medtronic sofamor danek).Imploants used for the peek cages were from a competitor.All patients were followed up radiologically for 24 months.The article did not specify which of the devices were being used to capture the following complications: 70 of 93 levels had nonunion.Cyst sign, just before surgery, the vertebral endplate cysts were detected at 7 levels in the ti group.Cyst formation and union status at 1 year after surgery: 16 nonunion patients had true postive, 7 nonunion patients had false negative, cyst formation and union status at 2 year after surgery: 9 nonunion patients had true postive, 7 nonunion patients had false negative, this report is for a devex cage (depuy synthes spine, raynham, ma).This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• 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: 10843605
• MDR Text Key: 218505227
• Report Number: 1526439-2020-02197
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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: 10/19/2020
• 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