MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH; SURGICAL MESH

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

Patient Problems Cerebrospinal Fluid Leakage (1772); 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 vertebral body replacement - mesh/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between june 2015 to june 2017.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: yang h (2019), anterior controllable antedisplacement fusion as a choice for 28 patients of cervical ossification of the posterior longitudinal ligament with dura ossification: the risk of cerebrospinal fluid leakage compared with anterior cervical corpectomy and fusion, european spine journal, vol.28, pages 370-379 (china).The purpose of this study is to compare the incidence rate of cerebrospinal fluid (csf) leakage between anterior controllable antedisplacement fusion (acaf) and anterior cervical corpectomy and fusion (accf) in the treatment of ossification of the posterior longitudinal ligament with dura ossification.Between june 2015 to june 2017, 28 patients with symptoms of cervical myelopathy who underwent acaf (17 males, 11 females; mean age 58.0+/- 9.9 years [range, 38¿74 years]) and 31 patients who underwent accf (21 males, 10 females; mean age 58.7 +/-7.9 years [range, 43¿73 years]) were included in the study.All patients were implanted with an unknown depuy spine skyline anterior cervical plate system with cage and titanium mesh (depuy synthes spine, raynham, ma, usa).Neurophysiologic monitoring including somatosensory-evoked potentials, spontaneous electromyogram, and/or motor-evoked potential intraoperatively was used in all patients.Complications were reported as follows: 7 patients in the accf group had dural tears which were all diagnosed intraoperatively because of clear fluid extravasating from the wound.Of these patients, 3 had a resolution of all signs and symptoms of the leak within 15 days; the other 4 within 30 days.1 patient in the acaf group had cerebrospinal fluid leakage.A pressure on the wound and suction via syringe were performed.Csf leakage disappeared in 10 days.This report is for the skyline anterior cervical plate system with cage and titanium mesh.This report is for one unknown vertebral body replacement - mesh.This is report 4 of 4 for (b)(4).

• Brand Name: UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH
• Type of Device: SURGICAL MESH
• 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: 9499300
• MDR Text Key: 188992244
• Report Number: 1526439-2019-52743
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• 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