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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 186770445
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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
(b)(6) hospital (b)(6) 2019: viper prime 7x45mm 186770445 screw was about to be inserted on patient and was not rigid, was loose and floppy. Further investigation illustrates the cocr saddle of the screw became disengaged and loose out of the tulip of the screw. Did the event occur during sterile processing? --> unknown, did the event occur during field inspection? --> unknown, did the event occur during internal service activities such as calibration? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown,.
 
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Brand NameVIPER PRIME CFXFEN XTAB 7X45MM
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 Key8455623
MDR Text Key144163310
Report Number1526439-2019-51490
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034509617
UDI-Public(01)10705034509617
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K170543
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 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186770445
Device Catalogue Number186770445
Device Lot NumberTBTMA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2018
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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