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

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

Patient Problems Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patients involved.Implantation date is unknown.This report is for an unknown concorde lift 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 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: chan a., et al (2019)a novel technique for awake, minimally invasive transforaminal lumbar interbody fusion: technical note, neurosurgical focus volume 46 (4), pages 1-8 (usa) https://thejns.Org/doi/abs/10.3171/2019.1.Focus18510.This study aims to report on the safety of using liposomal long-acting local anesthetics and show that methods to conduct mi-tlif without general anesthesia are reproducible.A total of two patients (1 male , 1 female) who underwent awake technique for minimally invasive transforaminal lumbar interbody fusion (mi-tlif) were included in the study.Awake minimally invasive transforaminal mi-tlif was done using the percutaneous pedicle screw (viper prime, depuy synthes) and interbody cage (concorde lift, depuy synthes).The following complications were reported as follows: a case of a of a (b)(6)-year-old man had scoliosis and meyerding grade i l4¿5 spondylolisthesis with low-back pain and left leg radiculopathy, including parasthesias.Two months after his initial surgery, he underwent an awake l4¿5 mi-tlif with neuronavigation.Immediate postoperative radiographs demonstrated the hardware in a good position.At the 3-month postoperative follow-up, the patient noted improvement in his sensory disturbance with only occasional burning pain on the medial dorsal aspect of his left foot at night when lying down.His pain was well controlled on acetaminophen alone and without narcotics.A case of a (b)(6)-year-old female with scoliosis, meyerding grade i l4¿5 spondylolisthesis, and moderate lumbar stenosis presented with left leg pain radiating from her buttocks to her calf that had lasted for 1 year.The patient underwent an awake l4¿5 mi-tlif with percutaneous screw fixation and interbody cage placement from the left with the aid of neuronavigation at the routine 3-month follow-up, the patient noted some right lateral hip pain and low-back pain.Her radiographs revealed postsurgical findings preoperative axial (e) and sagittal (f) t2-weighted mr images reveal l4¿5 lumbar stenosis.Dynamic extension (g) and flexion (h) lumbar plain radiographs demonstrate mobile spondylolisthesis.Intraoperative ap (i) and lateral (j) fluoroscopic images demonstrate the hardware in a good position (fig.3c and d).Her leg pain was much improved, and she had reduced her oxycodone use to once nightly.Her vas back pain score worsened from 0 to 6 postoperatively.Her vas leg pain score improved from 7.5 to 0 postoperatively.This report is for an unknown depuy spine percutaneous pedicle screw (viper prime) and interbody cage (concorde lift).This is report 1 of 6 for (b)(4).

• Brand Name: UNKNOWN CONCORDE LIFT CAGE
• 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 Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10432686
• MDR Text Key: 204186336
• Report Number: 1526439-2020-01494
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 07/28/2020
• 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