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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0306563000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2014
Event Type  malfunction  
Event Description
It was reported that prior to a procedure the acm cartridge broke.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device will not be returned as it was discarded by the user facility; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.
 
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Brand Name
ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE
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 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3941172
MDR Text Key4533659
Report Number0001811755-2014-02563
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0306563000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SIMPLEX P-JAPANESE TWIN PACK 61910002 (UNKNOWN)
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