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 Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an skyline 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: evaluation of healthcare outcomes of patients implanted with ecd-expandable corpectomy device during surgical fusion procedures of the cervical and upper thoracic spine: a real-world evidence external registry review, british spine registry ecd report, vol.Xx pages 1-15 (united kingdom).This study provides a descriptive assessment of patients implanted with expandable corpectomy device (ecd) during surgical procedures of the cervical and upper thoracic spine, as analyzed from the british spine registry (bsr).Between july 2011 and august 2019, a total of 21 patients (11 males and 10 females) underwent anterior corpectomy procedures.The mean age was 60.8 years.There were eight patients who received ecd for cervical corpectomy for the treatment of tumor.Additionally, 4 patients where treated with ecd for trauma and 9 patients where treated for cervicothoracic degenerative disease.Implants used were mountaineer oct spinal system was used in conjunction with the skyline anterior cervical plate system in 1 patient.Other implants used were from depuy synthes.The article did not specify which of the devices were being used to capture the following complications: there was intraop excessive bleeding-incomplete tumour resection.Complication was noted as a result of a reoperation to adjust the halo following the index surgery.In the case where surgeons performed an adjustment of the halo, staff noted ¿dysphagia that occurred after second procedure¿.This patient required a reoperation.The procedure described as ¿adjustment of a halo and not for the removal of metalwork¿.This report is for a skyline anterior cervical plates.It captures the reported intraop excessive bleeding-incomplete tumour resection, complication was noted as a result of a reoperation to adjust the halo following the index surgery.This is report 2 of 3 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10468930
• MDR Text Key: 204873501
• Report Number: 1526439-2020-01563
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

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
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/28/2020
• 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