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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELITE 14CM HOODED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
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STRYKER INSTRUMENTS-KALAMAZOO ELITE 14CM HOODED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) Back to Search Results
Catalog Number 5407120484
Device Problems Bent (1059); Flaked (1246)
Patient Problem No Patient Involvement (2645)
Event Date 01/12/2017
Event Type  malfunction  
Event Description
A manufacturer sales representative reported that during set-up for a demonstration at a user facility paint chips were missing from the device.There were no adverse consequences related to this event.It was reported that during testing at the manufacturer facility the hood on the device was bent.There were no adverse consequences related to this event.
 
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Brand Name
ELITE 14CM HOODED ATTACHMENT
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
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 Key6299493
MDR Text Key66434588
Report Number0001811755-2017-00475
Device Sequence Number1
Product Code HBE
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K143320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2017
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
Device Operator Other
Device Catalogue Number5407120484
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Initial Date Manufacturer Received 01/12/2017
Initial Date FDA Received02/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2015
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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