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 PD SERIES MAESTRO RIGHT ANGLE ATTACHMENT; 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 PD SERIES MAESTRO RIGHT ANGLE ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Model Number 5400210011
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/04/2020
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer sales representative reported that the device overheated during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The manufacturer sales representative reported that the device overheated during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.H3 other text : device not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PD SERIES MAESTRO RIGHT ANGLE ATTACHMENT
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 Key9907816
Report Number0001811755-2020-00848
Device Sequence Number644116
Product Code ERL
UDI-Device Identifier04546540469151
UDI-Public04546540469151
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 company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/22/2021
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 Number5400210011
Device Catalogue Number5400210011
Device Lot Number15103
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 04/22/2021
Supplement Date Received by Manufacturer04/22/2021
Initial Report FDA Received Date03/31/2020
Supplement Report FDA Received Date04/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-