T2 STRATOSPHEREEXPANDABLE CORPECTOMY SYSTEM 436120C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-02 for T2 STRATOSPHEREEXPANDABLE CORPECTOMY SYSTEM 436120C manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[183515857] Other: thigh pain. Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183515858] It was reported that the patient underwent posterior fixation, vertebral body replacement at l3 and anterior fixation was performed at l2-4 due to compression fracture at l3. It was unknown how much the cage backed out. The cage was placed in the state that the adjusting end caps were free according to the surgical technique, and the cage was lengthened. It was said the cage did not reach the vertebral body end plate during lengthening, and maybe the set screw on the side of the adjusting end caps side was not loosened enough, so the set screw was loosened after removal, and insertion was performed again, and at that time the cage was lengthened successfully. After placement, it was checked whether the cage moves using a spatula of the facility, and there was no problem. Post-operatively, the cage placed backed out towards the approached side. By checking the post-operative x-ray image, it seemed that the upper end plate side had not fit slightly. The patient had pain in the thigh.
Patient Sequence No: 1, Text Type: D, B5


[187446809] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2020-00001
MDR Report Key9537454
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-02
Date of Report2020-03-11
Date of Event2019-12-03
Date Mfgr Received2020-02-19
Date Added to Maude2020-01-02
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Street4340 SWINEA RD
Manufacturer CityMEMPHIS TN 38118
Manufacturer CountryUS
Manufacturer Postal Code38118
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT2 STRATOSPHEREEXPANDABLE CORPECTOMY SYSTEM
Generic NameSPINAL VERTEBRAL BODY REPLACEMENT DEVICE
Product CodeMQP
Date Received2020-01-02
Model NumberNA
Catalog Number436120C
Lot NumberCA18J204
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-02

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