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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 Problems Tissue Damage (2104); Injury (2348)
Event Type  Injury  
Manufacturer Narrative

There are multiple patients all information is provided in the article. This report is for an unknown mono/polyaxial screw/unknown lot. Part and lot number are unknown; udi number is unknown. Implant date is between july to september 2003. 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: mizuno, k. Et al (2005), intraoperative insertion torque of lumbar pedicle screw and postoperative radiographic evaluation: short-term observation, journal of orthopaedic science, vol. 10 (2), pages 137-144 (japan). The aim of this study is to analyzed the factors that affect insertion torque use with a custom-made torquemeter driver in vivo. Between july to september 2003, a total of 23 patients (5 male and 18 female) with an average age of 68 years (range 49-86 years) underwent lumbar pedicle screw fixation. Surgery was performed using moss miami system (depuy spine, raynham, ma, usa) in 8 patients (10-disc levels). Follow-up was unknown. The following complications were reported as follows: 17 screws showed "cortex cutting" (screw threads cut into the anterior cortex of the vertebral body). In the moss miami group, one-disc level with radiolucent zones was observed, and one level with motion of more than 5° and with a radiolucent zone was seen; there were two of eight-disc levels that showed ¿3-month instability. ¿ this report is for an unknown moss-miami. This report is for one unknown mono/polyaxial screws. This is report 7 of 8 for (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
SZ
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key9494990
MDR Text Key188901817
Report Number1526439-2019-52728
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
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 Received11/26/2019
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: 12/19/2019 Patient Sequence Number: 1
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