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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP® 3D 3.1 - SOFTWARE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP® 3D 3.1 - SOFTWARE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6002-680-000
Device Problems Imprecision (1307); Improper or Incorrect Procedure or Method (2017); Unintended Application Program Shut Down (4032)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
Per the customer when completing point-to-point registration an error message showed "point position not accepted. This point was already digitized. " each time when trying to digitize points. After shutting down software, rebooted, revalidated instruments, then able to successfully complete point-to-point registration and use navigation to complete the case. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand NameSPINEMAP® 3D 3.1 - SOFTWARE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM D-79111
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key12830289
MDR Text Key280900710
Report Number3015967359-2021-02581
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number6002-680-000
Device Catalogue Number6002-680-000
Device Lot NumberVERSION: 3.1-19/019
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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