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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER STRYKER DRILLS, BURRS, TREPHINES AND ACCESSORIES

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STRYKER STRYKER DRILLS, BURRS, TREPHINES AND ACCESSORIES Back to Search Results
Model Number 5407-120-970C
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 10/06/2017
Event Type  malfunction  
Event Description
Patient undergoing laminectomy when the drill attachment unexpectedly became hot and caused a burn to the skin adjacent to the lumbar incision.
 
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Brand NameSTRYKER
Type of DeviceDRILLS, BURRS, TREPHINES AND ACCESSORIES
Manufacturer (Section D)
STRYKER
MDR Report Key6950923
MDR Text Key89616365
Report NumberMW5072752
Device Sequence Number1
Product Code HBG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5407-120-970C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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