MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: SKYLINE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Break (1069)

Patient Problems Abscess (1690); Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Pain (1994); Osteolysis (2377); Paresthesia (4421); Unspecified Nervous System Problem (4426); Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) "evaluation of health-related outcomes for patients treated with the depuy synthes skyline anterior cervical plate (acp)" for 22 patients [17 male and 5 female; mean age was 56.5 (sd 17.3); mean bmi was 27.3 (sd 6.7)] with either had tumor or trauma treated between (b)(6) 2014 and (b)(6) 2021 at upstate orthopedics, the state university of new york, syracuse.Patients treated with anterior cervical fusion procedures, either anterior cervical discectomy and fusion (acdf) or anterior cervical corpectomy and fusion (accf).Skyline plate was used as supplemental fixation in all patients.Complications were reported as follows: intraoperative ae: dural tear (n=1).Prior to discharge ae: dysphagia <3 months (n=1).Hypotension (n=1).Infection (n=1).Neurological injury (n= 1).Tachycardia (n=1).Postoperative ae: abscess ¿ required reoperation (n=1).Adjacent segment stenosis (n=1).Dysphagia < 3 months (n=3).Dysphagia >3 months (n=3).Dysphagia (unknown timeline) (n=1).Hardware failure ¿ pi indicated related to skyline (same patient as other skyline related aes) ¿ required revision (n=1).Neurological injury (n=1).Pain ¿ pi indicated related to skyline (same patient as other skyline related aes) ¿ required revision (n=1).Pain ¿ not device related (n=3) paresthesia (n=1).Pseudarthrosis- pi indicated related to skyline ¿ required revision (n=1).Radiculopathy ¿ pi indicated related to skyline ¿ required revision (n=1).Other (n=1).Serious ae: death-cause not known (n=1).Abscess ¿ led to reoperation (n=1).Neurogenic shock ¿ lead to death (n=1).Hardware failure (broken screws at c5) ¿ led to revision (n=1).Pain (n=1).Radiculopathy (n=1).Pseudarthrosis (n=1).( are adverse events that occurred in same patient).This is for depuy spine skyline anterior cervical plate system.This is report 2 of 3 for complaint (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

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.Additional narrative: this report is for an unknown screws: skyline/unknown lot.Part and lot numbers are unknown; udi 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 - SCREWS: SKYLINE
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 16351981
• MDR Text Key: 309278964
• Report Number: 1526439-2023-00224
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,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: 02/10/2023
• 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: 01/18/2023
• 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