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 2010-08-06 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[1570514] It was reported that pts with a history of humeral nonunions were treated with rhbmp-2. After adequate bone preparation and reduction, locking plates were applied. Minimal contouring was needed. Six to eight cortices were used on either side on the nonunion site. In one pt, despite some bone formation, union had not occurred after one year. No infection was observed. Revision with the same technique was required and union was achieved ten months later.
Patient Sequence No: 1, Text Type: D, B5


[8683457] Literature citation: crawford et al. Atrophic nonunion of humeral diaphysis treated with locking plate and recombinant bone morphogenetic protein: nine cases. The american journal of orthopedics, 2009; 38(11): 567-570. A review of the device history records is not possible without add'l device info. Neither the device nor imaging films were returned to the mfr for eval. Therefore, we are unable to determine the definitive cause of the reported event. (b)(4): pseudoarthrosis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2010-01030
MDR Report Key1793154
Report Source03,05
Date Received2010-08-06
Date of Report2010-07-16
Date of Event2009-11-01
Date Mfgr Received2010-07-16
Date Added to Maude2010-08-17
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 CodeMPW
Date Received2010-08-06
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 2010-08-06

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