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 2010-09-07 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[1705641] It was reported that complications were observed in pts who had undergone anterior cervical discectomy and fusion (acdf) augmented with high-dose rhbmp-2. The surgical procedure was performed using a modified surgical technique. Decompression and decortication were carried out and the cage was filled with rhbmp-2. Add'l rhbmp-2 was also placed lateral and anterior to the graft within the disc space - up to 2. 1 mg/level was used. An anterior cervical plate was then placed. Intraoperative radiograph confirmed proper alignment and fixation of the bone graft and plate. It was reported that two pts who had undergone a 2-level acdf developed a hematoma. A drain was placed - surgical evacuation was not required. No details or outcomes were mentioned.
Patient Sequence No: 1, Text Type: D, B5


[8704159] (b)(4). Literature citation: shields et al. Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 used in anterior cervical spine fusion. Spine. 2006; 31: number 5, pp 542-547. Device was not returned to the mfr for eval. Without add'l device info, a review of the device history records is not possible. We are, therefore, unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2010-01145
MDR Report Key1831026
Report Source03,05
Date Received2010-09-07
Date of Report2010-08-16
Date of Event2005-03-14
Date Mfgr Received2010-08-16
Date Added to Maude2010-09-14
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 CodeMPW
Date Received2010-09-07
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 2010-09-07

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