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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606563000
Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 08/12/2019
Event Type  malfunction  
Event Description
The user facility reported when opening up the package, the inside wrap/packaging was stuck to outside wrap.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Additional information added for d4, d10, h3, h4 device evaluation: follow-up report submitted to document device evaluation results.H3 other text : device discarded.
 
Event Description
The user facility reported when opening up the package, the inside wrap/packaging was stuck to outside wrap.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
highway #3, km 130.2
kalamazoo MI 49001
MDR Report Key8940954
MDR Text Key155860115
Report Number0001811755-2019-02829
Device Sequence Number1
Product Code JDZ
UDI-Device Identifier34546540912092
UDI-Public34546540912092
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606563000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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