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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 Therapeutic Effects, Unexpected (2099)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
It was reported that the acm syringe broke at the connection to the cement gun during a procedure.The cement was set into the canal by hand by the surgeon.The initial cement and stem needed to be removed which resulted in a total delay of four hours for preparation and removal.The procedure was completed successfully with no further impact to the patient or user.
 
Manufacturer Narrative
Incomplete device returned.
 
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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 Key4332504
MDR Text Key5137979
Report Number0001811755-2014-04547
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 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0306563000
Device Lot Number14224012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2014
Was Device Evaluated by Manufacturer? No
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 (B)(4)
Patient Age74 YR
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