Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-KALAMAZOO CRANIALMAP SOFTWARE; ORTHOPEDIC 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-KALAMAZOO CRANIALMAP SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6000-660-000
Medical Device Problem Code Image Orientation Incorrect (1305)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/24/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the cranial software was not accurate during case.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Event or Problem Description
It was reported that during a procedure at the user facility the cranial software was not accurate during case.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CRANIALMAP SOFTWARE
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8085626
Report Number0001811755-2018-02499
Device Sequence Number1770523
Product Code HAW
UDI-Device Identifier07613327327199
UDI-Public07613327327199
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K162937
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) 02/26/2019
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 No Information
Device Catalogue Number6000-660-000
Device Lot Number15317
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 10/24/2018
Supplement Date Received by Manufacturer02/26/2019
Initial Report FDA Received Date11/19/2018
Supplement Report FDA Received Date02/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-