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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP GO - SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP GO - SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6002-690-000
Device Problems Imprecision (1307); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Event Description
It was reported that during a product demonstration at the user facility the device was inaccurate.No medical intervention and no adverse consequences were reported with this event.As this event occurred during a product demonstration at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : the system log files were not available for review.
 
Event Description
It was reported that during a product demonstration at the user facility the device was inaccurate.No medical intervention and no adverse consequences were reported with this event.As this event occurred during a product demonstration at the user facility, there was no patient involvement and no delay to a surgical procedure.
 
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Brand Name
SPINEMAP GO - SOFTWARE
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11869953
MDR Text Key252170134
Report Number3015967359-2021-00945
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327412994
UDI-Public07613327412994
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 08/20/2021
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 Model Number6002-690-000
Device Catalogue Number6002-690-000
Device Lot NumberVERSION: 1.0-29/030
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/12/2021
Initial Date FDA Received05/24/2021
Supplement Dates Manufacturer Received08/18/2021
Supplement Dates FDA Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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