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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT BATTERY; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-006-000
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2017
Event Type  malfunction  
Event Description
It was reported that at inspection at the user facility a foreign particle was found in the sterile packaging of the instruments battery.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
INSTRUMENT BATTERY
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7048122
MDR Text Key93199389
Report Number0001811755-2017-02366
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540245045
UDI-Public(01)04546540245045
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6000-006-000
Device Catalogue Number6000006000
Device Lot Number2017021284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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