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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 Migration (4003)
Patient Problem Tissue Damage (2104)
Event Date 07/14/2017
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: chiu kc,chan cyw, kwan mk (2017), the accuracy and safety of fluoroscopic-guided percutaneous pedicle screws in the thoracic and lumbosacral spine in the asian population: a ct scan analysis of 1002 screws, journal of orthopaedic surgery, volume 25, page 1-8, https://doi. Org/10. 1177/2309499017713938 (malaysia). This retrospective study aims to review the safety and accuracy of percutaneous pedicle screws among malaysians which consist of a multiethnic asian population. Between january 2008 and december 2014, 128 patients who had surgery using fluoroscopic-guided percutaneous pedicle screws were included in the study. There were 70 male patients and 58 female patients with a mean age of 52. 7+/-16. 6. A total of 1002 pedicle screws were implanted with mean screws per patient of 7. 8 +/-2. 1, mean stabilized levels of 6. 8+/-2. 6, and screw density of 1. 4+/- 0. 90. The screws used were the unknown depuy spine viper system and a competitor¿s screw system. Complications were reported as follows: there was a total of 113 (11. 3 percent) screw perforations. 84 grade 1 (less than 4 mm perforation) screw perforations. 26 grade 2 (4 to 6 mm perforation) screw perforations. 3 grade 3 (more than 6 mm perforation) screw perforations. Depuy spine products: this report is for the unknown depuy spine viper screw system. It captures reported event of screw perforation. This is report 1 of 1 for complaint (b)(4).

 
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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 Key9570406
MDR Text Key189450566
Report Number1526439-2020-00329
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received12/16/2019
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: 01/09/2020 Patient Sequence Number: 1
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