INFUSE BONE GRAFT 7510050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-07-14 for INFUSE BONE GRAFT 7510050 manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[6030028] It was reported that four rhbmp-2/acs xxs kits used on three different patients. Post-op, all the three patients came back within a period of 8-10 months and minimal bone was formed, but skin was healed. The surgeon reported this event because this was a different reaction than he had ever seen with his use of rhbmp-2/acs in his omf practice.
Patient Sequence No: 1, Text Type: D, B5


[13764359] (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10


[32589674] Image review: ct provided is coronal/axial cuts. Imaging provided shows a paucity of bone at implant site. Unclear what implicating for grafting at this location are based on history provided.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2015-01446
MDR Report Key4911422
Report Source05,HEALTH PROFESSIONAL
Date Received2015-07-14
Date of Report2015-09-15
Date Mfgr Received2015-09-15
Date Added to Maude2015-07-14
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 ContactGREG ANGLIN
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK
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 NameINFUSE BONE GRAFT
Generic NameBONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT
Product CodeNPZ
Date Received2015-07-14
Model NumberNA
Catalog Number7510050
Lot NumberM111306AAH
Device Expiration Date2015-03-31
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 2015-07-14

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