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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL SPEED CEMENT INJECTION GUN; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO DUAL SPEED CEMENT INJECTION GUN; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0206600000
Device Problem Metal Shedding Debris (1804)
Patient Problem No Patient Involvement (2645)
Event Date 03/21/2017
Event Type  malfunction  
Event Description
It was reported that during testing, small metal fragments became detached from the device.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
We have evaluated the device.
 
Event Description
It was reported that during testing, small metal fragments became detached from the device.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
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Brand Name
DUAL SPEED CEMENT INJECTION 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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6521101
MDR Text Key73666128
Report Number0001811755-2017-00884
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0206600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received08/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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