MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown bullet-shaped concorde cage/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer 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.

Event Description

This report is being filed after the review of the following journal article: sun k., et al (2020) a modified procedure of single-level transforaminal lumbar interbody fusion reduces immediate post-operative symptoms: a prospective case-controlled study based on two hundred and four cases, international orthopaedics volume 44, pages 935¿945 (china).This prospective case-controlled study aims to confirm the effect of the modified procedure named ¿rod-prior-to-cage tlif¿ on the immediate post-operative symptoms and illustrated the possible reasons.From january 2017 to february 2019, a total of 204 patients who had single-level lumbar disc herniation accompanied with stenosis at l3/4, l4/5, or l5/s1 and required single-level open tlif were enrolled in this study.Patients were divided into group r (rod prior-to-cage) in which the installation of bilateral rods was performed prior to the insertion of the cages and group c (cage-prior-to-rod) where the placement of the cage was conducted prior to the installation of bilateral rods.Either group r or group c has 102 patients, including 56 males and 46 females in group r with an average age of 51.75 ± 1.90 years and 60 males and 42 females in group c with an average age of 53.75 ± 1.59 years.All patients in this present study received the same kind of cage, the bullet-shaped concorde cage (depuy spine, raynham, ma, usa).All the patients in this study were followed up at least one month.The following complications were reported: three patients in group r experienced surgery-related complications: two with lumbar haematoma and one with csf leakage.In group c, the number of patients with complications was four: two with lumbar haematoma, one with wound infection, and one with csf leakage.Alleviation of original symptoms (pain/numb) only 94 patients in group r and 81 in group c.A total of 22 patients suffered immediate post-operative symptoms: new-onset pain/numb after operation, of whom 17 patients were from group c and only five patients were from group r.During the follow-up period, all five patients in group r and ten patients in group c were resolved spontaneously within three weeks, while the other seven patients in group c acquired spontaneously complete improvement at the fourth week after their discharge.This report is for an unknown depuy spine bullet-shaped concorde cage.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, 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: 10773267
• MDR Text Key: 215096826
• Report Number: 1526439-2020-02078
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 10/07/2020
• 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