MIS TI CFX FEN POLY 7X40 186727740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-04 for MIS TI CFX FEN POLY 7X40 186727740 manufactured by Medos International Sàrl Ch.

Event Text Entries

[129599835] (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.
Patient Sequence No: 1, Text Type: N, H10


[129599836] The following was reported: detachment of the head of the screw from the stem, when screwing in the screw with the help of the screwdriver.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2018-51125
MDR Report Key8130088
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2018-12-04
Date of Report2018-11-16
Date of Event2018-01-01
Date Mfgr Received2019-02-05
Device Manufacturer Date2018-10-19
Date Added to Maude2018-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1MEDOS INT SPINE
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIS TI CFX FEN POLY 7X40
Generic NameBONE CEMENT, POSTERIOR SCREW AUGMENTATION
Product CodePML
Date Received2018-12-04
Model Number186727740
Catalog Number186727740
Lot Number219578
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-04

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