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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEMAP GO - SALES DEMO; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO SPINEMAP GO - SALES DEMO; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 81-81041
Device Problems Image Display Error/Artifact (1304); Image Orientation Incorrect (1305)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2019
Event Type  malfunction  
Event Description
It was reported that during a surgery, it was observed that the orientation of the instrument was wrong in the ap image.The possible harm associated with inaccuracy during a procedure is revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
 
Event Description
It was reported that during a surgery, it was observed that the orientation of the instrument was wrong in the ap image.The possible harm associated with inaccuracy during a procedure is revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
 
Manufacturer Narrative
Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
SPINEMAP GO - SALES DEMO
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9175731
MDR Text Key161847277
Report Number0001811755-2019-03214
Device Sequence Number1
Product Code OLO
UDI-Device Identifier07613327413007
UDI-Public07613327413007
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number81-81041
Device Catalogue Number81-81041
Device Lot Number1000354432
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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