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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X50MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X50MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 186770450
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Physician indicated that screw shaft was inside the cup and because of that it was impossible to implement the rod. No consequences for the patient reported. Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: unknown). This complaint involves one (1) device.
 
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Brand NameVIPER PRIME CFXFEN XTAB 7X50MM
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
SZ
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9193473
MDR Text Key176843032
Report Number1526439-2019-52250
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034509624
UDI-Public(01)10705034509624
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K170543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186770450
Device Catalogue Number186770450
Device Lot NumberTBVNB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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