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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL MEDIUM STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL MEDIUM STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015250
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2015
Event Type  malfunction  
Event Description
It was reported that during use at the user facility the bur would not stay in place and was slipping out.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was tested by a manufacturer service technician and the device was found to be operating within specification.
 
Event Description
It was reported that during use at the user facility the bur would not stay in place and was slipping out.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
Type of Device
UNIT, 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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4962353
MDR Text Key6256534
Report Number0001811755-2015-02825
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100015250
Device Lot Number13107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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