MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Hematoma (1884); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown viper screw/rod construct/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.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.

Event Description

This report is being filed after the review of the following journal article: meleis a., et al (2021) single-center outcomes for percutaneous pedicle screw fixation in metastatic spinal lesions: can spontaneous facet fusion occur?, neurosurg focus volume 50 (5), pages 1-7 (usa) this single-center, descriptive, retrospective study aims to report outcomes of percutaneous stabilization using cement augmentation of pedicle screws in the management of spinal metastasis and to provide an analysis of the radiographic evaluation of hardware integrity and fusion.Between april 2015 and august 2019, 74 patients (35 females and 39 males) with neoplastic spinal instability who underwent percutaneous instrumented spinal stabilization with cement augmentation of fenestrated pedicle screws with clinical, radiological follow-up for at least 6 weeks postoperatively were included in the study.During the procedure, viper fenestrated screws (depuy synthes) and vertaplex bone cement (stryker) were used.Patients were evaluated within 1 month of surgery to assess pain scale and postoperative checks.Individuals were followed up at 3 and 6 months postoperatively and annually afterward.The median length of clinical follow-up was 5 months.The following complications were reported as follows: one patient had a surgical site muscular hematoma.27 patients demonstrated nonfusion.Three patients had hardware failure: one was involved in a car accident that caused a rod fracture requiring operative repair, another was found to have a broken screw 18 months following the initial operation, and the last patient had lucency surrounding one of the screws 3 months postoperatively.The latter two did not require surgical intervention as the patients were asymptomatic.This report is for unknown depuy spine viper screw/rod construct.This report captures the reported events of one patient who had a surgical site muscular hematoma and 27 patients who demonstrated nonfusion.A copy of the literature article is being submitted with this medwatch.This is report 1 of 4 for complaint (b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: VIPER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13793823
• MDR Text Key: 287354634
• Report Number: 1526439-2022-00404
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• 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: 02/15/2022
• 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