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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE & ADV. FEM. PRESS.; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO REVOLUTION CMS W/ FEMORAL BREAKAWAY NOZZLE & ADV. FEM. PRESS.; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606593000
Device Problem Biocompatibility (2886)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
Discarded by the customer.
 
Event Description
The user facility reported that the when the packed was opened, a black material was on the lid prior to a procedure.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 & ADV. FEM. PRESS.
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7070817
MDR Text Key93359378
Report Number0001811755-2017-02384
Device Sequence Number1
Product Code JDZ
UDI-Device Identifier4546540447913
UDI-Public(01)4546540447913
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
Reporter Occupation Other
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606593000
Device Lot Number17103012
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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