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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE FEN SCR 6.0X40 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE FEN SCR 6.0X40 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 199723640S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2022
Event Type  malfunction  
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Brand Name5.5 EXP VERSE FEN SCR 6.0X40
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 02400
SZ   02400
3035526892
MDR Report Key15321955
Report Number1526439-2022-01503
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034443492
UDI-Public(01)10705034443492
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K173095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199723640S
Device Catalogue Number199723640S
Device Lot Number338383
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2022
Is the Device Single Use? Yes
Type of Device Usage Unkown

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