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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 10/24/2018
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.
 
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.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
CRANIALMAP SOFTWARE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8085626
MDR Text Key127619772
Report Number0001811755-2018-02499
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327327199
UDI-Public07613327327199
Combination Product (y/n)N
PMA/PMN Number
K162937
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/26/2019
1 Device was Involved in the Event
1 Patient was 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 No Information
Device Catalogue Number6000-660-000
Device Lot Number15317
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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