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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 186715000
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Additional product code kwp; kwq; mnh; mni; osh. (b)(4). 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for a revision surgery. The patient had posterior lumbar interbody fusion (plif) at l3/iliac treating tumor in the sacrum spine on (b)(6) 2020. It was found that on (b)(6) 2020, the rod had come off and set screws are displaced. It was unknown if the revision surgery successfully completed. The patient outcome was unknown. This complaint involves four (4) devices. This report is for (1) mis single inner set screw. This is report 4 of 4 for (b)(4).
 
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Brand NameMIS SINGLE INNER SETSCW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10868744
MDR Text Key217162498
Report Number1526439-2020-02238
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034121192
UDI-Public10705034121192
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186715000
Device Catalogue Number186715000
Device Lot Number279718
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2020
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: 11/19/2020 Patient Sequence Number: 1
Treatment
5.5 EXP VERSE UNITIZED SET SCR; MIS SINGLE INNER SETSCW; UNKNOWN RODS
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