MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VERTAPLEX HV SINGLE PACK; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0406622015

Device Problem Migration (4003)

Patient Problems Paraplegia (2448); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during the procedure, cement extravasated into what appears to be the spinal canal.Attempts are currently being made to gain more information around this event and the patients status.

Event Description

It was reported that during the procedure, cement extravasated into what appears to be the spinal canal.Upon follow up it was reported that the patient was woken up to determine motor function, the patient has minimal movement in lower extremities but has preserved sensation.It was additionally reported that the medical intervention used as a result of this event, was decompression laminectomy with duraplasty to evacuate subdural hematoma.

Manufacturer Narrative

H2: additional information: patient status known and medical intervention used.D1: part number and lot number provided.E4: medwatch reports mw5149753 and mw5149754 were received for this event h6: the quality investigation is complete.H3 other text: device implanted.

• Brand Name: VERTAPLEX HV SINGLE PACK
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill MI NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill, MI NA ; EI NA ; 2693237700
• MDR Report Key: 18354583
• MDR Text Key: 330872021
• Report Number: 0001811755-2023-00243
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0406622015
• Device Lot Number: VCE019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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
• Treatment: 0607687000; 0607687000 AUTOPLEX SYSTEM
• Patient Outcome(s): Disability; Other