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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: meier u, kemmesies d, (2004), experiences with 6 different intervertebral disc spacers for spondylodesis of the cervical spine, orthopäde, volume 33, pages 1290-1299, (germany).This study aims to compare different interposition devices, also known as intervertebral disc spacers, disc spacers or cages, and to assess them in terms of intraoperative, anatomical, and design-specific performance characteristics, x-ray contrast and x-ray artifacts, implant costs and the clinical course of the patient¿s disease.From september 1, 1997 to january 1, 2003, 267 patients who underwent ventral cervical fusion surgery for degenerative diseases of the cervical spine were included in the study.There were 120 men and 147 women with a mean age of 49 (range, 25-70) years.The patients underwent smith-robinson technique with the caspar instrumentation under microsurgical conditions.For the study, 6 different spacers were used randomly without prior selection; 4 of these were titanium, 1 was peek and another was carbon.A total of 17 patients were implanted with the unknown depuy spine carbon fiber reinforced polymer cervical cage while the rest of the patients were implanted with competitors¿ devices.The patients underwent a clinical examination immediately pre- and postoperatively and then 3 months and 1 year after surgery.The japanese orthopedic association score (joa score, was applied to assess the clinical symptoms; all significant symptoms with which patients presented could be attributed to either radiculopathy or myelopathy.All 267 patients who underwent surgery were available for follow-up 3 months after surgery.A total of 245 patients were available for the follow-up examination 1 year postoperatively.The follow-up period lasted until january 01, 2004.Complications were reported: 3 patients had spacers that penetrated the inferior and/or superior endplate of the adjacent vertebral bodies at 3 months after ventral spondylodesis.3 patients had spacers that penetrated the inferior and/or superior endplate of the adjacent vertebral bodies at 1 year follow-up.1 patient had revision surgery that was required to address ventral kinking of the cervical spine caused by the penetration of the cage, especially into the superior endplate of the lower vertebral body, and the return of clinical symptoms.The patient underwent ventral plate osteosynthesis and spondylodesis using autologous bone chips according to the bailey-badgley technique.There was a reported difficulty to identify the contrast of the spacer¿s tantalum bodies sufficiently in the lower cervical spine because the shoulder girdle overlaps this region.This report is for the unknown depuy spine carbon fiber reinforced polymer cervical cage.This report is for (1) unknown cage/spacer.This report is 1 of 2 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 2400 ; SZ 2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11987299
• MDR Text Key: 257172252
• Report Number: 1526439-2021-01217
• 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: 05/19/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/11/2021
• 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