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

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Osteolysis (2377)

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.Investigation summary: 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

This report is being filed after the review of the following journal article: pourtaheri s, et al.(2013), cervical corpectomy with ultra-low-dose rhbmp-2 in high-risk patients: 5-year outcomes, orthopedics, volume 36, number 12, pages 931-935, (usa).This study evaluated the clinical and radiographic outcomes of using 0.26 to 0.35 mg/ml of rhbmp-2 in cervical corpectomies in patients who were considered high risk for pseudarthrosis (tobacco smokers and patients with diabetes mellitus).Between august 2007 and december 2009, 24 patients who underwent cervical corpectomy with low-dose rh-bmp-2 were included in the study.There were 13 men and 11 women with a mean age of 60+/-9 years.All anterior fusions were performed through a smith-robinson approach.The rh- bmp-2 was prepared at a concentration of 0.26 to 0.35 mg per level with local autograft from the corpectomy and demineralized bone matrix in a polyetheretherketone (peek) spacer (unknown depuy spine bengal spacer).All patients received a cervical drain and were intubated at the end of the operation.Postoperatively, a hard collar was worn for 2 weeks, followed by a soft collar for another 2 weeks.6 weeks postoperatively, therapy was initiated.All patients were assessed clinically postoperatively at 2 and 6 weeks, 6 months, 1 year, and then annually.Mean follow-up was 5 years (range, 3.5-6 years).Complications were reported as follows: 14 patients had hoarseness at 2-week follow-up which resolved in all but 2 patients.12 patients had dysphagia (8 mild, 3 moderate, and 1 severe).9 patients continued to have dysphagia at 6 weeks (8 mild, 1 moderate).5 patients had dysphagia at 6 months (5 mild).4 patients had dysphagia at latest follow-up (mean, 4.5 years).10 patients had resorption at 2 weeks.4 patients had developed heterotopic ossification posterior to the graft.4 patients had postoperative adjacent segment degeneration.Only 1 of the patients was symptomatic, and it was addressed with a 1-level anterior cervical fusion without rhbmp-2; symptoms resolved with no dysphagia at 6-week and 2-year follow-up.4 patients had subsidence.None of the cases was symptomatic.This report is for the unknown depuy spine bengal spacer.This report is 2 of 2 for (b)(4).This impacted product captures the following events: hoarseness, dysphagia, resorption, heterotopic ossification, adjacent segment degeneration.

• 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 2400 ; SZ 2400
• MDR Report Key: 11958018
• MDR Text Key: 254865105
• Report Number: 1526439-2021-01175
• Device Sequence Number: 1
• Product Code: ODV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention