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 2010-08-13 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[1358954] It was reported that the pt had less than 4mm of residual crestal bone requiring bilateral sinus augmentation. The lateral sinus wall was exposed, a complete osteotomy was made and the lateral window bone was discarded. Initial sinus membrane release was accomplished and extended up the medial wall of the sinus - no perforations were observed. Preparation of rhbmp-2/acs was done per mfr's instructions. The sinuses were grafted with infuse graft at a concentration of 1. 5 mg/ml/acs combined a mineralized allograft. The collagen sponges were compressed after a 15-minute binding period to remove any excess water. Half of the particles were 0. 5 to 1 mm and half were 1 to 2 mm. On the left side, two sponges were cut into strips and mixed with the allograft as a composite graft, while four spongs were used on the right. The total volume of rhbmp-2 on the right was twice that used on the left. Barrier membranes were not used over the lateral window. Extensive postoperative inflammatory response was observed, which had resolved by the 6-month evaluation.
Patient Sequence No: 1, Text Type: D, B5


[8776535] (b)(4). Literature citation: tamrow, et al. Maxillary sinus augmentation using recombinant bone morphogenetic protein-2/acellular collagen sponge in combination with a mineralized bone replacement graft: a report of three cases. Int j periodontics restorative dent 2010;30:139-149. A review of the device history records is not possible without additional device info. Neither the device nor (test results or imaging films) were returned to the mfr for evaluation. 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 Number1030489-2010-01050
MDR Report Key1805098
Report Source03,05
Date Received2010-08-13
Date of Report2010-07-18
Date of Event2010-01-01
Date Mfgr Received2010-07-18
Date Added to Maude2010-08-20
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 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 Received2010-08-13
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. Required No Informationntervention 2010-08-13

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