KYPHON HV-R BONE CEMENT C01A

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 2020-01-18 for KYPHON HV-R BONE CEMENT C01A manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[184666193] 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


[184666194] It was reported that the patient presented with compression fracture at t12; and underwent balloon kyphoplasty. Intra-op, when the balloon was inflated to 4cc, the balloon interfered with the endplate. There was no malfunction with the balloon. When the cement was filled to 3. 5cc, the cement leaked to the left side; however, the procedure was completed successfully with the same product. No patient complications were reported due to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00088
MDR Report Key9604697
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-18
Date of Report2020-01-18
Date of Event2019-12-20
Date Mfgr Received2019-12-20
Date Added to Maude2020-01-18
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 NameKYPHON HV-R BONE CEMENT
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-01-18
Model NumberNA
Catalog NumberC01A
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
10 2020-01-18

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