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 03,05 report with the FDA on 2010-05-28 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[1402586] It was reported that the pt underwent a cleft repair procedure using rhbmp-2/acs. It was reported that the cleft site repair failed to meet radiographic criteria of dental arch fusion; however, the aesthetic result was pleasing, and possibility for subsequent grafting exists. Per the reporter, failure in this particular case was attributed to excessive irrigation of the implant site before final closure, leading to a "dilution effect" of protein from the sponge. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5


[8576440] (b) (4). Non-union. Literature article citation: fallucco et al. Primary reconstruction of alveolar clefts using recombinant human bone morphogenic protein-2; clinical and radiographic outcomes. The journal of craniofacial surgery 2009; 1759-1764. A review of the certificates of analysis and packing list for the infuse bone graft was not possible without additional device info. Neither the device nor films of applicable imaging studies were returned to the manufacturer for eval. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2010-00755
MDR Report Key1705940
Report Source03,05
Date Received2010-05-28
Date of Report2010-04-28
Date of Event2009-01-23
Date Facility Aware2009-01-23
Report Date2010-04-28
Date Mfgr Received2010-04-28
Date Added to Maude2010-06-04
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 Location3
Manufacturer ContactCHAD ASHTON
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 NameINFUSE BONE GRAFT
Product CodeNPZ
Date Received2010-05-28
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
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 2010-05-28

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