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 Problems Unspecified Infection (1930); Pain (1994); Hypoesthesia (2352); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.

Event Description

Device report from germany reports an event as follows: this report is being filed after the review of the following journal article: linhardt o., grifka j., benditz a., (2015) are there segmental differences of lumbar spondylodesis? - comparison of the segments l iv/v and l v/s i in patients with transforaminal lumbar intracorporal fusion (tlif), zeitschrift für orthopädie und unfallchirurgie volume 153, pages 546-551(germany) doi: 10.1055/s-0035-1557908.This prospective study aims to present the operative results of open tlif spondylodesis of segment l v/s i in comparison to segment l iv/v, considering its special anatomical conditions.Between 1/2011 and 1/2014,a total of 60 patients were operated on for degenerative spinal disease with corresponding symptoms using spondylodesis in open tlif technique were enrolled in the study.30 patients each were operated on monosegmentally in segment l iv/v (group 1) and l v/s i (group 2).30 patients (18 females, 12 males) with mean age of 54 years (32-79) in segment l iv/v (group 1) and 30 patients (20 females, 10 males) with mean age of 51 years (16-81) in segment l v/s i (group 2) were treated with tlif.All patients underwent distraction spondylodesis.The primary procedure was the insertion of the internal fixator (expedium system from depuy).Insertion of devex cage from depuy was also done.Patients were followed up 2 weeks and 12 months after surgery.The following complications were reported as follows: one patient in group 1 had to undergo revision surgery 2 days postoperatively due to a screw malposition.One patient in group 1 showed delayed wound healing, which healed without revision with antibiotic treatment.One patient in group 1 developed a pronounced degeneration in the underlying segment with severe pain symptoms 6 months postoperatively, necessitating a second operation with spondylodesis extending over two segments.Two weeks postoperatively, all patients were still taking nsaids because of wound pain.In addition, 3 patients in group 2 still needed opiates regularly because of severe painful dysesthesia.One year postoperatively, 7 patients in group 1 and 5 patients in group 2 occasionally took nsaids for mild back pain.This may be explained by reversible dysesthesias in 3 patients in group 2.Two patients from group 2 underwent dorsoventral spondylodesis using the alif technique, as an originally planned tlif was not possible due to highly contracted conditions.This procedure was not considered a complication.This report is for an unknown depuy spine expedium system and unknown depuy spine devex cage.This report is for (1) unknown cage/spacer.This is report 3 of 3 for (b)(4).

• 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10864345
• MDR Text Key: 218528596
• Report Number: 1526439-2020-02233
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention