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 report with the FDA on 2015-01-05 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[5366166] It was reported in a literature article which compared the results of treating nonunion with either bone morphogenetic protein (bmp)-7 or bmp-2, that between 2001 and 2009, 214 limb segments were treated for nonunion with either bmp-7 or bmp-2. One hundred thirty eight limb segments (112 patients) received bmp-2. There were 45 tibiae, 43 femora, and 50 humeri treated. Eighty-eight percent (121 of 138 limb segments) received autograft and bmp-2, and 12% received bmp-2 only (14 limb segments) or allograft plus bmp-2 (3 limb segments). Twenty-nine percent of limb segments (40 of 138) were treated with an adjunctive external bone growth stimulator. Patients who had the bone stimulator were encouraged to use it as soon as they received it. Radiographic healing occurred in 129 (93%) of 138 limb segments at an average of 19 weeks (range, 2-53) after surgery. Eighty-eight percent of limb segments (122 of 138) were full weight bearing (clinically healed) at the completion of the study. The average time to weight bearing was 15 weeks (range, 0-53) after surgery. The average time to weight bearing was 15 weeks (range, 0-53) after surgery. The average followup was 17 months (range, 3-56). Thirty-two subjects, across both groups, had more than 1 surgical procedure for bone grafting. Seven patients (7 limb segments) received both bmp-7 and bmp-2 in the same limb segment during different surgical procedures. These 7 patients underwent treatment with bmp-7 and did not heal. They underwent treatment with bmp-2 at an average of 22 months (range, 6-57) after the initial treatment with bmp-7. After treatment with bmp-2, all patients healed at an average of 18 weeks (range, 10-22). The complication rate in the bmp-2 group was lower (9%) than in the bmp-7 group (17%). One patient in the bmp-2 group experienced regenerate collapse requiring additional surgery.
Patient Sequence No: 1, Text Type: D, B5


[12613434] Literature citation: conway et al. ? Bmp-7 versus bmp-2 for the treatment of long bone nonunion?. Orthopedics. 2014; 37(12):e1049-e1057. (b)(6). (b)(4). Neither the device nor patient medical records 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/used 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 Number1030489-2015-00015
MDR Report Key4381750
Report Source03
Date Received2015-01-05
Date of Report2014-12-06
Date of Event2014-12-01
Date Mfgr Received2014-12-06
Date Added to Maude2015-01-05
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 NameFILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOIN
Product CodeMPW
Date Received2015-01-05
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
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. Required No Informationntervention 2015-01-05

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