MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN PLATES; PLATE, FIXATION, BONE

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

Patient Problems Dysphagia/ Odynophagia (1815); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown anterior cervical plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: xu, z.Et al.(2019), anterior cervical discectomy and fusion versus hybrid decompression and fusion for the treatment of 3-level cervical spondylotic myelopathy: a comparative analysis of cervical sagittal balance and outcomes, world neurosurgery, vol.132, pages e752-e758 (china).The objectve of this study is to compare the cervical sagittal balance and surgical outcomes between anterior cervical discectomy and fusion (acdf) and hybrid decompression and fusion (hdf; 1-level corpectomy combined with 1-level discectomy) for consecutive 3-level cervical spondylotic myelopathy (csm).From january 2013 to june 2016, a total of 82 patients (52 males and 30 females with a mean age of 55.6 +/ 12.1 years) underwent anterior decompression and fusion.These patients were divided into 2 groups: the acdf group (40 patients) and the hdf group (42 patients).Implants used were (bengal, depuy spine, raynham, massachusetts, usa), titanium meshes (depuy spine) and an anterior cervical plate (slimloc, depuy spine).These patients were followed up for 35.5 +/ 6.5 months (range, 25-53 months).The following complications were reported as follows: 5 patients had axial symptoms.1 patient had hoarseness.1 patient had dysphagia.1 patient had pseudoarthrosis.This report is for an unknown synthes an anterior cervical plate.It captures the reported event of axial symptoms, hoarseness, 1 patient had dysphagia, pseudoarthrosis.This is report 1 of 4 for (b)(4).

• Brand Name: UNKNOWN PLATES
• Type of Device: PLATE, FIXATION, BONE
• 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 02767 ; SZ 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10938689
• MDR Text Key: 219318773
• Report Number: 1526439-2020-02343
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

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: 11/09/2020
• Initial Date FDA Received: 12/03/2020
• 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