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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX 20 GRAM TWIN PACK (1/2 DOSE); CEMENT, BONE, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX 20 GRAM TWIN PACK (1/2 DOSE); CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 0406402000
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2015
Event Type  malfunction  
Event Description
It was reported that upon opening the vertaplex cement the sterile packaging of the liquid monomer was pulled back and the top of the ampule was cracked open.The procedure was completed successfully with no adverse consequences, medical intervention or clinically significant delay.
 
Event Description
It was reported that upon opening the vertaplex cement the sterile packaging of the liquid monomer was pulled back and the top of the ampule was cracked open.The procedure was completed successfully with no adverse consequences, medical intervention or clinically significant delay.
 
Manufacturer Narrative
Upon returned product evaluation, it was concluded that the most probable cause for this event was forceful impact/vibration of the product during shipping transit and/or customer handling/storage.The device was discarded by the manufacturer.
 
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Brand Name
VERTAPLEX 20 GRAM TWIN PACK (1/2 DOSE)
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
highway #3, km 130.2
kalamazoo MI 49001 006
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key4696701
MDR Text Key5676862
Report Number0001811755-2015-01404
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0406402000
Device Lot NumberVGV030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/09/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4) PCD W/STRAIGHT SHORT TUBE
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