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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 186715000
Device Problem Migration (4003)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative

Additional procode: kwp; kwq; mnh; mni; osh. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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

Device report from synthes reports an event in (b)(6) as follows: on (b)(6) 2021 it was reported that the patient underwent a spinal fusion at l3 left treating interbody fracture. On (b)(6) the patient was x-rayed in the medical follow-up. It was found that the setscrew at l3 had come off. On mar. 17 the patient underwent a revision procedure. They also found that the inside of the monoaxial screw had been damaged. No fragment was left in the patient¿s body. The surgeon commented that the patient had a large physique which might have put stress to the devices. No further information is available. Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown). This report is for one (1) mis single inner setscw. This is report 2 of 2 for (b)(4).

 
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Brand NameMIS SINGLE INNER SETSCW
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 Key11666422
MDR Text Key245495099
Report Number1526439-2021-00721
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number186715000
Device Catalogue Number186715000
Device LOT Number275811
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/14/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/03/2020
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: 04/14/2021 Patient Sequence Number: 1
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