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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
MDR Report Key7601011
MDR Text Key111058822
Report Number0001811755-2018-01064
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
Type of Report Initial,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6007-008-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Date Manufacturer Received07/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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