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 2019-05-17 for MIS TI CFX FEN POLY 7X40 186727740 manufactured by Medos International Sàrl Ch.

Event Text Entries

[145414005] (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


[145414006] It was reported that the patient underwent 1st surgery on (b)(6) 2018, fusion l5-s1 with expedium and t-pal. On (b)(6) 2018, revision surgery because of radiculopathy and suspicion on infection. Implants where loose, have been removed and replaced. Post op pain free. Tissue has been examined in bacteriology, one sample was positive. Patient showed up in (b)(6) with back pain, examinations have shown again pseudarthrosis and loosening of the implants. On (b)(6), again revision surgery, removal of all implants, which have been sent in for bacteriological examination. Several tissue samples will also be examined bacteriologically. T-pal cage will be removed from anterior after these results of the bacteriological examination are known.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2019-51654
MDR Report Key8620995
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-05-17
Date of Report2019-04-29
Date of Event2019-04-29
Date Mfgr Received2019-07-17
Device Manufacturer Date2018-11-01
Date Added to Maude2019-05-17
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 Received2019-05-17
Returned To Mfg2019-06-04
Model Number186727740
Catalog Number186727740
Lot Number221799
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-05-17

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