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 Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: yang, h.Et al.(2021), anterior canal reconstruction and fusion for myelopathy caused by degenerative cervical kyphosis and stenosis with or without ossification of the posterior longitudinal ligament, clinical spine surgery, vol.Xx, pages 1-9 (china).The objective of this retrospective study was to introduce an anterior surgical technique for myelopathy caused by degenerative cervical kyphosis and stenosis (dcks) with or without ossification of the posterior longitudinal ligament (opll).From june 2017 through june 2019, a total of 41 patients with symptoms of cervical myelopathy underwent acrf [26 males, 15 females; mean age 57.7 ± 13.5 y (range, 46¿78 y)] using the skyline (depuy synthes spine, ma) and atlantis (medtronic sofamor danek, tn) anterior cervical plate system.Follow-up was carried out at 3, 6, 12, 24, and 36 months postoperation.The mean follow-up was 20.3±8.4 months (range, 12¿36 mo).The following complications were reported as follows: 1 patient had csf leakage which disappeared in 1 week after lumbar cisterna drainage.1 patient presented with screw displacement in c3 vertebra, which may be related to the osteoporosis.Fortunately, it was stable at 12th month after operation when reaching solid fusion.2 patients presented with dysphagia, which disappeared 3 months after operation.This is report 1 of 3 for (b)(4).This report is for an unknown synthes skyline plate (depuy synthes spine, ma).

• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12228313
• MDR Text Key: 263545670
• Report Number: 1526439-2021-01524
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• 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