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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 06/07/2019
Event Type  malfunction  
Event Description
It was reported that the nav3i is losing accuracy during cases and the unit was not able to be used because of the unit losing accuracy.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Event Description
It was reported that the nav3i is losing accuracy during cases and the unit was not able to be used because of the unit losing accuracy.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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 Key8748318
MDR Text Key149643339
Report Number0001811755-2019-02162
Device Sequence Number1
Product Code OLO
UDI-Device Identifier07613327327199
UDI-Public07613327327199
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/24/2019
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 Number6000-660-000
Device Lot NumberVERSION: 3.0-13/16
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/10/2019
Initial Date FDA Received07/01/2019
Supplement Dates Manufacturer Received07/24/2019
Supplement Dates FDA Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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