MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER 2; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number UNK - CONSTRUCTS: VIPER 2

Device Problem Device Slipped (1584)

Patient Problem Nerve Damage (1979)

Event Date 03/01/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: tannoury c, et al.(2022), the role of minimally invasive percutaneous pedicle screw fixation for the management of spinal metastatic disease, world neurosurgery 159: e453-e459, https://doi.Org/10.1016/j.Wneu.2021.12.069 (usa).The authors in this study present their experience with the minimally invasive percutaneous pedicle screw fixation (mipsf) technique, short (s, less than 6 vertebrae) versus long (l, 6 or more vertebrae), for the management of spinal metastatic disease.Between january 2012 and october 2020, 24 patients (10 female, 14 male) who underwent minimally invasive percutaneous pedicle screw fixation for spinal metastatic disease were included in the study.The mean age of patients was 65.0 years (range 30 to 85; standard deviation [sd] 11.7 years) with a mean body mass index of 26.5 (range 17.8 to 36.0; sd 4.7).Surgeries were performed using a single system for percutaneous pedicle screw instrumentation unknown depuy spine viper 2.Patients were divided into 2 groups: those who had 6 or more levels of fixation (long, l-mipsf), and those with less than 6 levels of fixation (short, s-mipsf).The mean postoperative duration of follow-up was 5.1 months (range 0.1e19 months) among patients receiving long segment fixation and 4.8 months (range 0.4e16 months) among patients receiving short segment fixation.Complications were reported as follows: 1 patient required reoperation with hardware revision and reinstrumentation due to proximal loss of fixation at the t3 upper instrumented vertebra secondary to progression of the destructive neoplastic process, which developed 9 months after the index operation.Extension of fixation to t2 (upper instrumented vertebra þ1) with cement vertebral augmentation was subsequently performed uneventfully.2 patients had new epidural spinal metastatic disease expansion with neural compromise developed within the instrumented l-mipsf segments.These changes developed after adjuvant chemoradiations were stopped due to either intolerance or severe adverse effects (neutropenia), and required limited laminectomy to alleviate the resulting cord compression.A 68-year-old male patient remained intubated and died during hospital stay due to his medical comorbid conditions.10 patients succumbed to their primary tumor burden upon final follow-up.This report is for the unknown depuy spine viper 2.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown constructs: constructs: viper 2/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.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.

• Brand Name: UNK - CONSTRUCTS: VIPER 2
• 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 ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18072923
• MDR Text Key: 327396445
• Report Number: 1526439-2023-02212
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,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: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: VIPER 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• 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