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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 VIPER PRIME¿

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X45MM VIPER PRIME¿ Back to Search Results
Model Number 186770445
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Patient Involvement (2645)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional pro-codes: kwp; kwq. Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. 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 synthes reports an event in (b)(6) as follows: it was reported that the surgeon started inserting 7 x 45 mm screw into pedicle with 5 mm of stylet advanced. After tapping screwdriver over the stylet, the screw kept skiving off and the screw became loose, and not holding its trajectory. Upon closer investigation it looked like the cocr saddle had become loose. Both screwdriver and screw are available for collection. This is a consignment viper prime screwdriver and viper prime 7 x 45 mm screw. Both need replacing immediately to buderim private consignment kit. Expedium thoracic probes, straight were opened on consignment and loan trays, both were bent and needed to be replaced. All items have been tagged. Surgery was delayed 10 minutes due to the reported event. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NameVIPER PRIME CFXFEN XTAB 7X45MM
Type of DeviceVIPER PRIME¿
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key9416713
MDR Text Key169274836
Report Number1526439-2019-52584
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 11/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186770445
Device Catalogue Number186770445
Device Lot NumberNW153808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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