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 CORE UNIVERSAL DRIVER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  • 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 CORE UNIVERSAL DRIVER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400099000
Medical Device Problem Code Device Remains Activated (1525)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/09/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device had run on testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device had run on testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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
CORE UNIVERSAL DRIVER
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8812924
Report Number0001811755-2019-02325
Device Sequence Number11360180
Product Code ERL
UDI-Device Identifier04546540401977
UDI-Public04546540401977
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
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) 08/05/2019
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 Health Professional
Device Catalogue Number5400099000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Initial Date Received by Manufacturer 07/09/2019
Supplement Date Received by Manufacturer08/02/2019
Initial Report FDA Received Date07/22/2019
Supplement Report FDA Received Date08/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-