KYPHX HV-R BONE CEMENT 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 2020-02-25 for KYPHX HV-R BONE CEMENT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[184329892] The following products have been used in the surgery: part# cx01a; lot# el70141; 510k# k102397; udi# (b)(4); qty# 1 part# cx01b; lot# 0010023931; 510k# k102397; udi# (b)(4); qty# 1. It is unknown which of these cement has extravasated. 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


[184329893] Cement extravasation was not extruded > 15 mm it was reported via clinical study that patient underwent cementoplasty (kyphoplasty) surgery at inferior disk space. 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 Number1030489-2020-00197
MDR Report Key9748727
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2020-01-24
Date Mfgr Received2020-01-31
Device Manufacturer Date2019-08-20
Date Added to Maude2020-02-25
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 NameKYPHX HV-R BONE CEMENT
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-02-25
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 Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25

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