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 POINTER, STRAIGHT; 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-KALAMAZOO POINTER, STRAIGHT; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007-011-000
Medical Device Problem Code Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility the tip was bent.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 surgical procedure at the user facility the tip was bent.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
POINTER, STRAIGHT
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8475825
Report Number0001811755-2019-01072
Device Sequence Number1465629
Product Code HAW
UDI-Device Identifier04546540392114
UDI-Public04546540392114
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
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) 04/19/2019
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 Number6007-011-000
Device Lot Number12329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Initial Date Received by Manufacturer 03/12/2019
Supplement Date Received by Manufacturer04/18/2019
Initial Report FDA Received Date04/02/2019
Supplement Report FDA Received Date04/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-