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 SPINE TRACKER; 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 SPINE TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6002-005-000
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/07/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a surgical procedure a screw fell out of the device on the scrub table.There were no adverse consequences or procedural delays as a result of the event.
 
Event or Problem Description
It was reported that during a surgical procedure a screw fell out of the device on the scrub table.There were no adverse consequences or procedural delays as a result of the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPINE TRACKER
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key6676285
Report Number0001811755-2017-01351
Device Sequence Number16161287
Product Code HAW
UDI-Device Identifier04546540350176
UDI-Public(01)04546540350176
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K012380
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/31/2018
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 Health Professional
Device Model Number6002-005-000
Device Catalogue Number6002-005-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2017
Initial Date Received by Manufacturer 06/07/2017
Supplement Date Received by Manufacturer08/15/2017
Initial Report FDA Received Date06/29/2017
Supplement Report FDA Received Date01/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-