MIS TI CFX FEN POLY 7X50 186727750S2P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-20 for MIS TI CFX FEN POLY 7X50 186727750S2P manufactured by Medos International Sàrl Ch.

Event Text Entries

[145547601] (b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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


[145547602] It was reported that on an unknown date, during spinal fusion, dr. (b)(6) brought the patient back to the operating room for a non-union. Both rods broke at l4, where no screws were placed from the previously implanted construct (t9-ilium). The original t9-ilium construct used expedium cocr rods. When the removal occurred, dr. (b)(6) noticed that the screws bilaterally at l5, s1 and l3 on the right. Dr. (b)(6) decide to remove those screws and replace them by upsizing each screw by 1mm in diameter. There was no surgical delay. Procedure was successfully completed. There was no patient harm/consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2019-51667
MDR Report Key8625216
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-20
Date of Report2019-04-30
Date Mfgr Received2019-04-30
Date Added to Maude2019-05-20
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 7X50
Generic NameBONE CEMENT, POSTERIOR SCREW AUGMENTATION
Product CodePML
Date Received2019-05-20
Catalog Number186727750S2P
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-20

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