• 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 POWERED INSTRUMENT DRIVER UNIT, OPERATIVE DENTAL

  • 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 POWERED INSTRUMENT DRIVER UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5400050000
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 09/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055. 1 device was received. 1 event was not duplicated; however, a cracked internal component was found. There were no remedial actions taken. This device is not labeled for single-use.
 
Event Description
This report summarizes 1 malfunction event, in which the device was reportedly leaking. There was no patient involvement; no patient impact.
 
Manufacturer Narrative
(b)(4). One event was reported for this quarter. One device was received. One device evaluation is in progress. There were no remedial actions taken. This device is not labeled for single-use.
 
Event Description
This report summarizes 1 malfunction event, in which the device was reportedly leaking. There was no patient involvement; no patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCORE POWERED INSTRUMENT DRIVER
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7219532
MDR Text Key176140644
Report Number0001811755-2018-00174
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5400050000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-