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

Catalog Number UNK CAGE/SPACER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Paresis (1998)

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.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: rabbo, f.A.Et al.(2020), long-term complications of minimally-open anterolateral interbody fusion for l5-s1, neurochirurgie, vol.66, pages 85-90 (france) the aim of this study was to report the long-term complications and fusion rates of minimally-open (mini-open) anterolateral interbody fusion at the l5-s1 level.During 2013, a total of 17 patients (8 males and 9 females) underwent mini-open anterolateral interbody fusion for l5-s1 level.All patients underwent a posterior fixation by pedi-cle screws.The mean population age was 64.5 years (45¿77 years).Implants used were synframe retractors (synthes®) and cougar (synthes) the following complications were reported as follows: a (b)(6) female patient had compressive hematoma that evolved to abscess.Fusion was acheived.A (b)(6) male patient had pain.Fusion was not achieved.A (b)(6) female patient had cage displacement.Fusion was acheived.A (b)(6) female patient had anemia and delirium.Fusion was acheived.A (b)(6) female patient had psoas paresis.Fusion was acheived.A (b)(6) male patient had ileus.Fusion was acheived.A (b)(6) male patient had psoas paresis.Fusion was acheived.A (b)(6) female patient had psoas paresis and anemia.Fusion was acheived.This report is for an unknown synthes cougar cage.This is report 6 of 6 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: 12282103
• MDR Text Key: 265209822
• Report Number: 1526439-2021-01622
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CAGE/SPACER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/05/2021
• 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
• Patient Age: 64 YR