• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX 20 GRAM TWIN PACK (1/2 DOSE) CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 0406402000
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Death (1802); Foreign Body In Patient (2687)
Event Date 02/28/2018
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information from the user facility regarding this event. Attempts are being made to obtain additional information from the user facility.
 
Event Description
It was reported that during the procedure, cement leaked into the patient's blood vessels. An adverse event of patient death was reported. Attempts are being made to obtain additional information from the user facility.
 
Manufacturer Narrative
Additional follow-up with the initial reporter confirmed that the initial report of the patient condition was in error.
 
Event Description
It was reported that during the procedure, the cement remained in a liquid consistency for longer than expected and leaked into the patient's blood vessels. The procedure was terminated after the leak was detected. There were no adverse consequences to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVERTAPLEX 20 GRAM TWIN PACK (1/2 DOSE)
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7462918
MDR Text Key106566451
Report Number0001811755-2018-00630
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K072118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0406402000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/25/2018 Patient Sequence Number: 1
-
-