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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. INFUSE BONE GRAFT

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MEDTRONIC SOFAMOR DANEK USA, INC. INFUSE BONE GRAFT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Airway Obstruction (1699)
Event Date 06/04/2010
Event Type  Death  
Event Description

In a retrospective single center cohort study of 260 pts, airway obstruction was reported in cases where rhbmp-2 was used in cervical spinal procedures performed between (b)(6) 2004 and (b)(6) 2009. No info about surgical procedures, levels implanted or specific pt conditions were given. The reporter stated the extensive soft-tissue inflammatory response reaction was most likely to occur 2 to 7 days after surgery. It is reported that pt death occurred within 90 days postoperatively in eleven cases. There is no info to suggest that the attending physician stated that any of the pt deaths were caused by the use of rhbmp-2, or that rhbmp-2 was a contributing factor. No details regarding cause of death were given.

 
Manufacturer Narrative

(b)(4). Literature citation: yaremchuk, et al. Acute airway obstruction in cervical spinal procedures with bone morphogenetic proteins. Laryngoscope 2010:000. A review of the device history records cannot be performed without additional device info. Without return of the device or associated records, it is not possible to ascertain a cause for the reported event.

 
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Brand NameINFUSE BONE GRAFT
Type of DeviceINFUSE BONE GRAFT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC.
4340 swinnea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC.
4340 swinnea rd
memphis TN 38118
Manufacturer Contact
chad ashton
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key1869234
MDR Text Key20939435
Report Number1030489-2010-01295
Device Sequence Number1
Product Code NEK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 09/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/09/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/04/2010 Patient Sequence Number: 1
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