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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; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 0607687000
Device Problem Device Inoperable (1663)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 06/06/2014
Event Type  Injury  
Event Description
It was reported that during a procedure the autoplex system was not mixing automatically, which caused a 20 minute delay in the procedure.It was reported that the patient received additional anesthesia as a result of the delay.The procedure was completed successfully utilizing back-up equipment.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.
 
Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
 
Event Description
It was reported that during a procedure the autoplex system was not mixing automatically, which caused a 20 minute delay in the procedure.It was reported that the patient received additional anesthesia as a result of the delay.The procedure was completed successfully utilizing back-up equipment.No adverse consequences were reported with this event.
 
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Brand Name
AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key4098502
MDR Text Key4718841
Report Number0001811755-2014-03282
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0607687000
Device Lot Number14052022
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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