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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0605887000
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2014
Event Type  malfunction  
Event Description
It was reported that during a procedure the motor of the autoplex was not functioning properly, causing the cement to be thrown from the device.The reported event resulted in a 60 minute delay.The procedure was completed successfully with no medical intervention and no adverse consequences reported.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
Event Description
It was reported that during a procedure the motor of the autoplex was not functioning properly, causing the cement to be thrown from the device.The reported event resulted in a 60 minute delay.The procedure was completed successfully with no medical intervention and no adverse consequences reported.
 
Manufacturer Narrative
The reported condition was confirmed to be related to an issue with the transfer tube that connects the mixing chamber with the injector assembly.Subject tubing inflated in such a way that it burst during cement transfer.Further inspection disclosed the inflation/burst was caused by a glue clog at the transfer tube¿s connector.This clogging did not allow the cement to flow to the injector assembly.Based on the investigation, it can be concluded that the failure was caused by the glue clog on the connector component.
 
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Brand Name
AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES
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 Key3943452
MDR Text Key4643689
Report Number0001811755-2014-02569
Device Sequence Number1
Product Code JDZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0605887000
Device Lot Number14086012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/11/2014
Initial Date FDA Received07/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2014
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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