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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER2 LORDOTIC ROD-120MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH VIPER2 LORDOTIC ROD-120MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 186788120
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. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4). 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 setscrews 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) viper2 lordotic rod-120mm. This is report 3 of 4 for (b)(4).
 
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Brand NameVIPER2 LORDOTIC ROD-120MM
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
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10868746
MDR Text Key217150945
Report Number1526439-2020-02236
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034131894
UDI-Public10705034131894
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111136
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 10/24/2020
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 Number186788120
Device Catalogue Number186788120
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 Received01/01/2021
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: 11/19/2020 Patient Sequence Number: 1
Treatment
5.5 EXP VERSE UNITIZED SET SCR; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW
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