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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

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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 Injury (2348)
Event Date 07/06/2018
Event Type  Injury  
Manufacturer Narrative
A total of 97 patients (45 males and 52 females) were treated with a viper2 or expedium system instruments. Exact date of event is unknown; (b)(6) 2018 is the date the literature article was published. This report is for an unknown mono/polyaxial screw/unknown lot. Part and lot number are unknown; udi 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: scarone, p. Et al. (2018), use of the airo mobile intraoperative ct system versus the o-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients, journal of neurosurgical spine, vol. 29, pages 397-406 (switzerland). The primary objective of this study was to compare the in vivo accuracy of these 2 navigation-enabling technologies during pedicular screw positioning at the thoracic and lumbar levels during percutaneous and open surgeries. Determining the rate of intraoperative screw repositioning, postoperative clinical results, surgical time, and radiation exposure were secondary objectives. Between january 2013 and november 2015, a total of 97 patients (45 males and 52 females) were treated with a viper2 or expedium system instruments. The following complications were reported as follows: (in this study, heary grade 1¿3 screws were considered correctly placed, and heary grade 4 and 5 screws were considered misplaced. ) 6 screws were heary grade 4. 7 screws were repositioned intraoperatively. A (b)(6) year old female patient experienced a partial motor deficit (m2) in her right foot after medial repositioning of an l5 pedicle screw in open surgery that needed a new intervention on postoperative day 1. The screw was classified as heary grade 4 on the final intraoperative ct image that was acquired before repositioning. The new screw position was not verified by an intraoperative scan. This report is for an unknown mono/polyaxial screws. This is report 5 of 10 for (b)(4). Additional devices are captured on related complaints (b)(4). A copy of the literature article is being submitted with this medwatch.
 
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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 Key9535837
MDR Text Key189176147
Report Number1526439-2019-52874
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 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
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 Received12/06/2019
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: 12/31/2019 Patient Sequence Number: 1
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