CEMENT, BONE, VERTEBROPLASTY UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-17 for CEMENT, BONE, VERTEBROPLASTY UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[183885555] 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


[183885556] Cement extravasation was not extruded > 15 mm location: superior disc space, intravascular it was reported via clinical study that patient underwent cementoplasty (kyphoplasty) surgery at l1,l5. Intra-op, cement extravasation occurred. No patient complications were reported during this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00326
MDR Report Key9846082
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-17
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-17
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal Code38132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCEMENT, BONE, VERTEBROPLASTY
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-03-17
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Address1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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