• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDOS INTERNATIONAL SàRL CH UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown mono/polyaxial screws/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Device available for evaluation: 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
This report is being filed after the review of the following journal article: kleck cj, et al. (2018). One-step minimally invasive pedicle screw instrumentation using o-arm and stealth navigation, clin spine surg, volume 31, page 197-202, (usa). This study describes the new techniques and evaluates safety in a series of patients who have undergone placement of pedicle screws with our minimally invasive technique. A total of 35 adult patients (187 screws) who underwent thoracolumbar spine fusion using 2- or 1-step minimally invasive pedicle screw placement were included in the study. There were 22 males and 13 females with an average age of 49 years old (range 28-67 years). Pedicle screws implanted to the patients include unknown depuy spine expedium pedicle screws. Follow-up ranged from 1 to 20 months complications were reported as follows: 2 grade 3 screws were found to be breached inferior at the time of the second intraoperative o-arm spin, and in both cases the screws were repositioned without neurological sequelae. 1 screw was found to protrude too far anteriorly (but fully contained within the pedicle) at s1 and was replaced with a shorter screw. 1 patient had a nonunion. At 1-year postoperative, the patient was having continued pain and a ct scan verified pseudoarthrosis at the l5¿s1 level. The patient underwent a revision posterior fusion procedure. 1 male patient was found to have a superficial deep vein thrombosis at 2 weeks postoperative. He had a positive family history of deep vein thrombosis. He was treated without further issue. Depuy spine products: this report is for the unknown depuy spine expedium pedicle screws. It captures the reported male patient with superficial deep vein thrombosis at 2 weeks postoperative. This is report 2 of 2 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN MONO/POLYAXIAL SCREWS
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9566200
MDR Text Key189439193
Report Number1526439-2020-00303
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
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 Received12/12/2019
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: 01/08/2020 Patient Sequence Number: 1
-
-