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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX HV GLOBAL TWIN PK; CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX HV GLOBAL TWIN PK; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 0406622000
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/09/2015
Event Type  malfunction  
Event Description
It was reported by the user facility that when they were unpacking their order that they found the device with broken glass and brown liquid.As this event occurred upon receipt at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Event Description
It was reported by the user facility that when they were unpacking their order that they found the device with broken glass and brown liquid.As this event occurred upon receipt at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
VERTAPLEX HV GLOBAL TWIN PK
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5177924
MDR Text Key29246398
Report Number0001811755-2015-03899
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0406622000
Device Lot NumberVEW020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
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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