MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO VERTAPLEX 20 GRAM TWIN PACK (1/2 DOSE); CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0406402000

Device Problem Activation, Positioning or Separation Problem (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.

• 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-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7462918
• MDR Text Key: 106566451
• Report Number: 0001811755-2018-00630
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 7613154757091
• UDI-Public: (01)7613154757091
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K072118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406402000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/21/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Death