MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Dysphagia/ Odynophagia (1815); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: chao d., et al (2019) new anterior cervical sliding plate in multilevel cervical spondylosis application of acdf, chinese journal of bone and joint injury , vol.34, no.7,pages 1-8 (china).This retrospective study aims to compare the effects of new cervical anterior sliding plate (atlantis translational) and conventional anterior cervical plate (skyline) in anterior cervical discectomy and fusion (acdf) surgery.From june 2017 to september 2018, 36 cases of multilevel cervical spondylosis treated with acdf were analyzed.Thirty-six patients were included.New anterior cervical sliding plate internal fixation was used in the operation (sliding plate group), and a conventional anterior cervical plate (skyline, fig.Johnson, usa) internal fixation (conventional plate group).In sliding plate group, there were 11 males and 5 females, aged (54.5 ± 8.4) years; in the conventional plate group, there were 14 males and 6 females, aged (55.4 ± 9.1) years.Follow-up was obtained for an average of 12 (8-16) months.Reported complication: a 9 cases in the conventional plate group had complications, including 6 cases of sore throat, 1 case of dysphagia; 1 case of cerebrospinal fluid leakage because the ligamentum flavum ossified and adhered to the dura mater seriously, the dura mater ruptured during intraoperative separation.A 1 case was poor in according to odom score during follow-up.A 1 case of x found that the lower fixing screw pulled out slightly, but the patient had no discomfort or neurological symptoms, so no treatment was given, and regular follow-up was told.This report is for unknown depuy spine skyline.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: skyline plate/screws/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.

• Brand Name: UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15121874
• MDR Text Key: 296777161
• Report Number: 1526439-2022-01296
• Device Sequence Number: 1
• Product Code: MNH
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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
• Date Manufacturer Received: 06/29/2022
• 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