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

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

Patient Problems Hematoma (1884); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown viper 2/expedium system/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.(b)(4).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 the following journal article: venier a., et al (2021) use of intraoperative computed tomography improves outcome of minimally invasive transforaminal lumbar interbody fusion: a single-center retrospective cohort study, world neurosurg.Volume 148, pages e572-e580 (switzerland).This study aims to describe clinical and radiologic results in a consecutive series of 100 patients who underwent mis tlif performed with a surgical technique based on navigated drill guides, tubular retractors, and 3d computed tomography (ict) imaging.Between january 2015 and january 2020, 730 patients with lumbar disorders underwent surgery with spinal fusion.Of these patients, 100 (56 male,44 female) age, mean 61 (27-84 years) were treated with mis tlif using a mobile ct scanner combined with a navigation system.Of these patients, 100 were treated with mis tlif using a mobile ct scanner combined with a navigation system.Cannulated pedicle screws with pre-calibrated instruments (viper 2/expedium system; depuy synthes, west chester, pennsylvania, usa) of appropriate size and length, connected to reduction towers, are inserted on the side contralateral to the tlif over the guidewires.The following complications were reported as follows: in one case, postoperative death occurred as a result of pulmonary embolism.19 lumbar screws presented a lateral breach of the pedicle for <2 mm (misplaced :13 screws with heary grade 2 and 6 screws with heary grade 3).Misplaced 2 sacral screws presented an anterior tip protrusion >2 mm.3 screws out of 408 (0.7%) were intraoperatively repositioned after the control scan.Two of these 3 screws initially had a higher degree of misplacement (i.E., heary grade 3 or higher), and this was the reason for repositioning.In 1 case, the screw was initially placed at a wrong level.5 dural tear.1 surgical infection.3 epidural hematoma.This report is for an unknown synthes viper 2/expedium system.It captures reported events of dural tear, surgical infection and 3 epidural hematoma.This is report 4 of 4 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12451228
• MDR Text Key: 270824889
• Report Number: 1526439-2021-01901
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

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: 08/12/2021
• Initial Date FDA Received: 09/09/2021
• 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