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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO REVOLUTION CEMENT GUN; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0606600000
Device Problem Metal Shedding Debris (1804)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2018
Event Type  malfunction  
Event Description
It was reported that prior to the procedure metal shavings were coming off of the device.There was no associated procedure; therefore, no surgical delay, medical intervention, adverse consequences or patient involvement were reported with this event.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that prior to the procedure metal shavings were coming off of the device.There was no associated procedure; therefore, no surgical delay, medical intervention, adverse consequences or patient involvement were reported with this event.
 
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Brand Name
REVOLUTION CEMENT GUN
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo MI 00615
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7185243
MDR Text Key97054785
Report Number0001811755-2018-00043
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0606600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/27/2018
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
Patient Sequence Number1
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