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 Impaired Healing (2378); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 2012 and december 2019.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: jung mk, et al.(2021), analysis of diagnostics, therapy and outcome of patients with traumatic atlanto-occipital dislocation, the spine journal, volume 000, pages 1-7, (germany).The aim of this retrospective study was to evaluate diagnostic parameters, therapy, early complications and outcome of patients with traumatic atlanto-occipital dislocation (aod).Between january 2012 and december 2019, 12 patients treated for traumatic aod were included in the study.There were 8 males and 4 females with a median age of 41.5 years.Closed reduction of traumatic aod was performed in all patients immediately after the diagnosis was made.Both surgical and non-surgical treatments were used for the treatment of aod in the study population.Non-surgical treatment consisted of immobilization of the cervical spine with a rigid cervical collar with a total of 5 patients were treated without surgery due to their unstable cardiopulmonary status.Closed reduction of traumatic aod was performed in all patients immediately after the diagnosis was made.Dorsal rigid occipito-cervical fixation was performed in 3 of 12 patients.Cervical instrumentation was performed with the unknown depuy spine mountaineer oct spinal system.The mean follow-up time was 6.7 months after hospital discharge (range: 1-24 months) and 8 months after injury (range: 1-48 months).Complications were reported as follows: 2 patients had surgical revision due to delayed wound healing.In 1 patient a tracheostomy had to be performed due to respiratory insufficiency.In 1 patient, a slight diastasis in the atlanto-occipital joint persisted.1 patient death (according to information in table 2).This report is for the unknown depuy spine mountaineer oct spinal system.This report is for one (1) unknown plate.This is report 1 of 2 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12099565
• MDR Text Key: 259374414
• Report Number: 1526439-2021-01371
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• 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: 06/09/2021
• 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