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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
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STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) Back to Search Results
Catalog Number 0607687000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2014
Event Type  malfunction  
Event Description
It was reported that during a procedure the autoplex system did not transport or provide enough cement, which resulted in a 30 minute delay in the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that during a procedure the autoplex system did not transport or provide enough cement, which resulted in a 30 minute delay in the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was discarded by the manufacturer.
 
Manufacturer Narrative
The manufacturer no longer considers this a reportable incident.   upon further investigation the user facility confirmed that the procedure was prolonged for 10 minutes rather than the 30 minutes initially reported.    .
 
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Brand Name
AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES
Type of Device
INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
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 Key3999009
MDR Text Key4956463
Report Number0001811755-2014-02830
Device Sequence Number1
Product Code OAR
Combination Product (y/n)N
Reporter Country CodeGM
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 07/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0607687000
Device Lot Number13322012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2013
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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