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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CRANIALMAP SOFTWARE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO CRANIALMAP SOFTWARE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-660-000
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2018
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the cranial software was not accurate during case. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand NameCRANIALMAP SOFTWARE
Type of DeviceORTHOPEDIC 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 Key8085697
MDR Text Key127606189
Report Number0001811755-2018-02508
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6000-660-000
Device Lot NumberVERSION: 3.0-13/16
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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