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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NGENIUS UNIVERSAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO NGENIUS UNIVERSAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-014-000
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/12/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during the service evaluation process conducted at the manufacturer facility it was observed that the screw of the battery compartment was broken off.This could lead to loose parts to fall on patient or into wound.No known patient involvement or procedural delays were reported with this event.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that during the service evaluation process conducted at the manufacturer facility it was observed that the screw of the battery compartment was broken off.This could lead to loose parts to fall on patient or into wound.No known patient involvement or procedural delays were reported with this event.
 
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Brand Name
NGENIUS UNIVERSAL TRACKER
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7312568
Report Number0001811755-2018-00473
Device Sequence Number18022085
Product Code OLO
Combination Product (Y/N)N
PMA/510(K) Number
K022579
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 06/26/2018
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
Operator of Device Health Professional
Device Catalogue Number6000-014-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Initial Date Received by Manufacturer 02/12/2018
Supplement Date Received by Manufacturer06/26/2018
Initial Report FDA Received Date03/05/2018
Supplement Report FDA Received Date06/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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