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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 279734000N
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/13/2021
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2021, when surgeon was instrumenting for an l5-s1 construct on a patient with sclerotic bone. The expedium navigation broke at the tip when inserting the third screw. The screw was fully seated at the time. The fragment could not be retrieved and the surgeon proceeded to instrument the last screw with a new driver and completed the construct. The procedure was successfully completed without surgical delay. There was no patient harm/consequence. This report involves one (1) universal navigation expedium spine system quick connect poly driver 5. 5. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: the device has been 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.
 
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Brand NameUNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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 Key12771108
MDR Text Key280464635
Report Number1526439-2021-02336
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279734000N
Device Catalogue Number279734000N
Device Lot NumberGM5358811
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/08/2021 Patient Sequence Number: 1
Treatment
UNKNOWN SCREWS
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