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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINE TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SPINE TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6002-005-000
Medical Device Problem Code Imprecision (1307)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/30/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during testing at the user facility the device was not accurate.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that during testing at the user facility the device was not accurate.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
SPINE TRACKER
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7637524
Report Number0001811755-2018-01093
Device Sequence Number1529628
Product Code OLO
UDI-Device Identifier04546540350176
UDI-Public04546540350176
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K141941
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/27/2018
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 Number6002-005-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Initial Date Received by Manufacturer 05/30/2018
Supplement Date Received by Manufacturer07/27/2018
Initial Report FDA Received Date06/26/2018
Supplement Report FDA Received Date07/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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