• 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 SCREW/ROD CONSTRUCT ACCESSORIES 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 SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Impaired Healing (2378); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown viper 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. 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: spiegl, u. J. Et al (2021), midterm outcome after posterior stabilization of unstable midthoracic spine fractures in the elderly, bmc musculoskeletal disorders, vol. 22 (188), pages 1-10, (germany). The aim of this retrospective study is to evaluate the clinical and radiographic midterm results of posterior stabilization for the treatment of unstable fractures of the midthoracic spine in patients aged 65 years or older. Between january 2010 to december 2017, a total of 59 patients (49% male and 51% female) with an average age of 76. 9 years (range 65 to 89 years) were included in the study. Posterior stabilization was done with cement-augmented pedicle screws (matrix, fa. Depuysynthes; viper, fa. Depuysynthes; competitor devices). Clinical and radiological follow-up was performed after 2, 6, 12 weeks, and 1 year after surgery. All patients were followed for at least 18 months after initial surgery. The average follow-up was 59. 9 months (median: 56. 6 months; range: 18¿111 months). The following complications were reported as follows: 21 patients (mean age at the time of surgery: 79. 4 years) died during the follow-up period. One of those patients died during postoperative hospital stay from a pulmonary embolism. Unknown number of patients had a mean radiologic loss of reduction of 5. 1° (range: 1°¿ 11°). 3 patients had wound healing disorders. 1 patient had mild pulmonary embolism. 5 patients underwent revision surgeries consisting of extension of the posterior stabilization in 3 patients because of adjacent fractures, removal of the implant in 1 patient due to implant-related complains and soft tissue revision due to a wound healing disorder in 1 patient. A total of 12 sequential vertebral fractures were seen during the follow-up period. 14 patients (41. 1%) had a minor disability, 17. 6% a moderate disability, 32. 3% a severe disability, and 3 patients (8. 8%) crippling back pain. A (b)(6) year-old female patient had low pain levels without any pain medication (vas: 2) at latest follow-up after 26 months. In a (b)(6) year-old female patient, an atraumatic subsequent fracture of the 3rd lumbar vertebral body occurred at the further course. At the latest follow-up after 69 months, the patient complained of permanent relevant pain (vas: 6), moderate limitations (odi: 45), and mild reduction loss as well as consolidated fracture 3rd lumbar body. This report is for an unknown depuy spine viper system. It captures the reported events of radiologic loss of reduction, wound healing disorders, mild pulmonary embolism, underwent revision surgeries, adjacent fracture, implant-related complains, sequential vertebral fractures, disability and crippling back pain. This is report 2 of 2 for (b)(4). This is a related complaint of (b)(4) (which involves synthes matrix).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
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 Key12071530
MDR Text Key263387919
Report Number1526439-2021-01310
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeGM
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 06/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
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: 06/25/2021 Patient Sequence Number: 1
-
-