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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NORTHERN DIGITAL, INC. NDI PASSIVE SPHERES; REFLECTIVE PASSIVE MARKER SPHERE - HAW, OLO
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NORTHERN DIGITAL, INC. NDI PASSIVE SPHERES; REFLECTIVE PASSIVE MARKER SPHERE - HAW, OLO Back to Search Results
Model Number 8800967
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2013
Event Type  malfunction  
Event Description
Complainant was concerned about accuracy of tracking due to a "loose and wobbly" sphere on a tool post.Inhouse testing was completed and did not show any concreted proof or failure mode attributable to ndi passive spheres.No "wobbly spheres" were found on any samples and during testing.This failure has not recurred since this report.No serious implications to this issue were mentioned by the complainant.No pt was harmed and no serious injury occurred.
 
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Brand Name
NDI PASSIVE SPHERES
Type of Device
REFLECTIVE PASSIVE MARKER SPHERE - HAW, OLO
Manufacturer (Section D)
NORTHERN DIGITAL, INC.
waterloo, ontario
CA 
Manufacturer Contact
gregory gotthelf
brecha e99 l15e
parque industrial reynosa
reynosa tam CP887-80
7166916333
MDR Report Key4170677
MDR Text Key5160765
Report Number3002743211-2014-00004
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K033621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8800967
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/29/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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