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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA GMBH GAMMA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA GMBH GAMMA ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3125-1180S
Device Problem Break (1069)
Patient Problem Fall (1848)
Event Date 12/10/2018
Event Type  malfunction  
Event Description
Patient had hip hardware of unknown timeframe. Fell at home with fall leading to break of the hardware. Fracture near femoral neck.
 
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Brand NameGAMMA
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA GMBH
2825 airview boulevard
portage MI 49002
MDR Report Key8270084
MDR Text Key133842051
Report Number8270084
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3125-1180S
Device Catalogue Number3125-1180S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2018
Event Location Other
Date Report to Manufacturer01/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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