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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VMX00CT-AVAMAX PLUS KIT; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO VMX00CT-AVAMAX PLUS KIT; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 1040300000
Device Problem Burst Container or Vessel (1074)
Patient Problem No Patient Involvement (2645)
Event Date 02/10/2017
Event Type  malfunction  
Manufacturer Narrative
Not being returned.
 
Event Description
It was reported that during a kyphoplasty procedure that the cement gun exploded and that new cement and bone fillers had to be used.There was no patient involvement, no medical intervention, no clinically significant delay and no adverse consequences associated with this event.
 
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Brand Name
VMX00CT-AVAMAX PLUS KIT
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6396933
MDR Text Key69745662
Report Number0001811755-2017-00745
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2017
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 Number1040300000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/10/2017
Initial Date FDA Received03/10/2017
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
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