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 04 report with the FDA on 2014-08-11 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[4692336] It was reported that the patient underwent an unspecified surgery in the lower jaw using rhbmp-2/acs. Post-op, the patient developed a swollen lower jaw that has been on-going for 2. 5 weeks since the surgery. The surgeon informed the patient that swelling could last 3-4 weeks. No additional information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5


[11934111] (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. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2014-03426
MDR Report Key3999966
Report Source04
Date Received2014-08-11
Date of Report2014-07-14
Date Mfgr Received2014-07-14
Date Added to Maude2014-08-12
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 FDA0
Event Location0
Manufacturer ContactHUZEFA MAMOOLA
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 Received2014-08-11
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
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
101. Other 2014-08-11

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