MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; POSTERIOR CERVICAL SCREW SYSTEM

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: yang x., et al (2020) the association of cervical sagittal alignment with adjacent segment degeneration, european spine journal volume 29, 2655¿2664 (the netherlands).This prospective randomized double-blind multicentre study aims to evaluate sagittal alignment parameters of the cervical spine in patients from two randomized double-blind trials on patients treated by anterior cervical discectomy with or without interbody fusion and arthroplasty for cervical radiculopathy at baseline and a 2-year follow-up.In the current study, 253 patients were included and randomly assigned into three groups: anterior cervical discectomy with arthroplasty (acda; activ ®c, aesculap ag, tuttlingen, germany ) with 85 patients (43 males and 42 females) age 44.8 ± 7.7 years, anterior cervical discectomy with fusion (acdf; cage standalone, depuy spine, johnson and johnson, amersfoort, the netherlands) with 85 patients (37 males and 48 females) age 45.6 ± 7.6 years and anterior cervical discectomy (acd) with 83 patients (42 males and 41 females) age 45.3 ± 6.7 years.At baseline, x-ray data were available for 228 patients and for 168 patients at 2-year follow-up.The following complications were reported: at 2-year follow-up, adjacent segment degeneration (asd) increased to 55% (28 patients) in the acdf group.C2¿c7 lordosis was found to increase from 11° to 13°.This report is for unknown depuy spine anterior cervical discectomy with fusion (acdf; cage standalone).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown cage/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.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: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 14653265
• MDR Text Key: 294854594
• Report Number: 1526439-2022-00822
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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

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: 05/13/2022
• Initial Date FDA Received: 06/10/2022
• 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