• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CRANIALMAP SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CRANIALMAP SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-660-000
Device Problems Imprecision (1307); Device Handling Problem (3265)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2022
Event Type  malfunction  
Event Description
Per the sales representative that was present during the case, images from a previous procedure were loaded onto the device at start up, which could lead to inaccuracies. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCRANIALMAP SOFTWARE
Type of DeviceNEUROLOGICAL 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
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key14515784
MDR Text Key292795008
Report Number3015967359-2022-01061
Device Sequence Number1
Product Code HAW
UDI-Device Identifier07613327327199
UDI-Public07613327327199
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 07/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number6000-660-000
Device Catalogue Number6000-660-000
Device Lot NumberVERSION: 3.0-13/016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-