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 Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown cage/spacer/unknown lot.Part and lot number 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.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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: kabir, smr, alabi j, rezajooi k & casey ath (2010), anterior cervical corpectomy: review and comparison of results using titanium mesh cages and carbon fibre reinforced polymer cages, british journal of neurosurgery, volume 24, number 5, pages 542-546, (uk).This article retrospectively reviews the experience with 42 patients who underwent single or multi-level anterior cervical corpectomy for various pathologies.Between november 2001 and september 2008, 42 patients who underwent anterior cervical corpectomy for various spinal pathologies were included in the study.There were 22 male and 20 female patients with a mean age of 60 years (range, 22 to 86).Reconstruction was done using two different types of cages: unknown titanium mesh cage (tmc) or unknown depuy spine leeds stackable carbon fiber reinforced polymer (cfrp) cage.The cfrp cage was implanted in 19 patients while the rest were implanted with the tmc.The patients had radiological and clinical follow-up at regular intervals.Complications were reported as follows: 3 patients had cerebrospinal fluid (csf) leak managed intraoperatively with dural reconstruction with artificial substitute and tissue glue (tissel).In 1 patient, a lumbar drain was also used.2 patients had persistent swallowing difficulty.1 patient had a hoarse voice.9 patients had fair outcome based on the odom¿s criteria.5 patients had poor outcome based on the odom¿s criteria.An (b)(6)-year-old patient developed severe cage subsidence (5mm).An (b)(6)-year-old patient had lobar intracerebral hemorrhage that occurred a few days after surgery.This did not require neurosurgical intervention.However, this patient subsequently died a few months later in the rehabilitation unit.1 male patient had a vertebral artery injury.This patient had an extensive chordoma involving c2.He subsequently underwent planned angiogram and balloon occlusion of the vertebral artery.4 patients died during the follow-up.2 of these patients had tumor and died of disease progression.A (b)(6)-year-old man died as a result of complications secondary to pre-existing recurrent hip dislocation related to total hip replacement surgery.His death was 4 months after his neck operation.A (b)(6)-year-old female patient with paraplegia secondary to spinal fracture and syringomyelia died 2 years following her corpectomy.Her death was due to complications secondary to respiratory tract infection.Depuy spine product: this report is for the unknown depuy spine leeds stackable carbon fiber reinforced polymer (cfrp) cage.This report is for one unknown cage/spacer.This is report 2 of 3 for pc-(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• 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
• MDR Report Key: 9535857
• MDR Text Key: 189224113
• Report Number: 1526439-2019-52880
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR