MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: UNIPLATE; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

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.Pma - 510k: this report is for an unknown screws: uniplate /unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.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 (ddra) "evaluation of healthcare outcomes of patients implanted with depuy synthes uniplate, uniplate2, vectra, and vectra-t during anterior fusion procedures in the cervical spine" for patients who underwent anterior fusion procedures in the cervical spine between january 1, 2005, and march 31, 2021.Among these patients were, 4,503 patients (2,344 male and 2,159 female; mean age of 53 years) in the uniplate/uniplate2 cohort; 10,452 patients (5,301 male and 5,151 female; mean age of 54 years) in the vectra cohort; and 933 patients (474 male and 459 female; mean age of 54 years) in the vectra-t cohort.The complications as per icd 9 & 10 categorization identified in premier healthcare database were reported as follows: uniplate/uniplate 2: n=6 had reoperation, 0-3 months (n=5 had infection diagnosis and n=1 had a dural tear); n=127 had revision, 0-12 months; n=68 had revision, 13-24 months.(among the total of 195 patients above who had revision, n;=10 had neck pain, n=26 had radiculopathy, n=35 had myelopathy, n=50 had a device-related complication, n=19 had pseudarthrosis, and n=8 had dysphagia).Vectra: n=16 had reoperation, 0-3 months (n=6 had an infection diagnosis, n=2 had a seroma, n=5 had a hematoma, and n=4 patients had a dural tear); n=358 had revision, 0-12 months; n=134 had revision, 13-24 months.(among the total of 492 patients above who had revision, n=9 had neck pain, n=38 had radiculopathy, n=94 had myelopathy, n=116 had a device-related complication, n=29 had pseudarthrosis, and n=30 had dysphagia).Vectra-t: n=23 had revision, 0-12 months; n=13 had revision, 13-24 months.(among the total of 36 patients above who had revision, n=1 had neck pain, n=1 had radiculopathy, n=9 had myelopathy, n=14 had a device-related complication, n=2 had pseudarthrosis, and n=2 had dysphagia).This report involves one unk - screws: uniplate.This is report 6 of 6 for (b)(4).Vectra devices mentioned in this database review were reported in (b)(4).

• Brand Name: UNK - SCREWS: UNIPLATE
• 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 ; SZ ; 3035526892
• MDR Report Key: 16520919
• MDR Text Key: 311130763
• Report Number: 1526439-2023-00458
• Device Sequence Number: 1
• Product Code: MNH
• 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: 03/10/2023
• 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: 02/17/2023
• 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