MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-17 for MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 UNK manufactured by Medtronic Inc..

Event Text Entries

[2902612] I had the infuse implanted during my surgery which has caused me extreme and excruciating pain. My movement has been restricted since my surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5028236
MDR Report Key2881690
Date Received2012-12-17
Date of Report2012-11-28
Date of Event2008-08-18
Date Added to Maude2012-12-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDTRONIC INFUSE BONE GRAFT OR RHBMP2
Generic NameMEDTRONIC INFUSE
Product CodeMPW
Date Received2012-12-17
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC INC.
Manufacturer AddressMINNEAPOLIS MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-12-17

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