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

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

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 - 510k: this report is for an unknown unk - constructs: skyline plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 a clinical evaluation report (cer) from a related research activity database (drra): depuy spinal implants subreport 2024 - conduit cervical found in swedish spine registry (swespine).Instrumentation with conduit cervical was performed in 210 patients between 2018 and december 31, 2023.28 cases combined with anterior plate of non-depuy brand were excluded, leaving 182 cases for analysis, including 125 cases combined with skyline.Mean age of the patients was 51 years.The following complications were reported: intraoperative complications: (n=2) dural injury (n=1) other postoperative complications within 1 year: (n=31) dysphagia (n=19) vocal cord dysfunction (n=3) infection (n=1) thrombosis reoperations: (n=1) adjustment implant (n=1) removal implant (n=1) redecompression (n=1) refusion (n=1) other this is for unknown depuy spine conduit and skyline for (b)(4).

• Brand Name: UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18949020
• MDR Text Key: 338231751
• Report Number: 1526439-2024-01098
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/21/2024
• 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