INFUSE BONE GRAFT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-14 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[132929992] (b)(6). 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


[132929993] It was reported that patient underwent unspecified surgery involving rhbmp-2. Patient was not sure if it was a cervical surgery. Post-op, when patient went to reach for things, or walk, patient felt very weird. Patient was diagnosed with multiple sclerosis on (b)(6) 2015. Patient had a scar on her neck that wouldn? T heal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2019-00049
MDR Report Key8244008
Report SourceCONSUMER
Date Received2019-01-14
Date of Report2019-01-14
Date Mfgr Received2018-12-18
Date Added to Maude2019-01-14
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 SWINNEA RD
Manufacturer CityMEMPHIS TN 38118
Manufacturer CountryUS
Manufacturer Postal Code38118
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINFUSE BONE GRAFT
Generic NameFILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Product CodeNEK
Date Received2019-01-14
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 SWINNEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-01-14

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