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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
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).
 
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Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL 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 Key12451228
MDR Text Key270824889
Report Number1526439-2021-01901
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/09/2021 Patient Sequence Number: 1
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