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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO INSTRUMENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-008-000
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
Event Type  malfunction  
Event Description
It was reported that during the service evaluation at the manufacturer facility, the device's battery compartment was found broken off.As this event occurred during the service evaluation process at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during the service evaluation at the manufacturer facility, the device's battery compartment was found broken off.As this event occurred during the service evaluation process at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
INSTRUMENT TRACKER
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7600929
MDR Text Key111034220
Report Number0001811755-2018-01063
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540392091
UDI-Public04546540392091
Combination Product (y/n)N
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6007-008-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/22/2018
Initial Date FDA Received06/14/2018
Supplement Dates Manufacturer Received07/16/2018
Supplement Dates FDA Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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