MAUDE Adverse Event Report: ORTHOVITA CORTOSS

Catalog Number 2101-0010

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 05/06/2013

Event Type  Injury  

Event Description

Cotoss cement leakage into canal and lateral to vertebra during thoracic spine vertebroplasty involving multiple levels.Post-op embolization of cotoss cement into pulmonary arteries necessitating icu admission and pulmonary radiology follow up.

• Brand Name: CORTOSS
• Type of Device: CORTOSS
• Manufacturer (Section D): ORTHOVITA; malvern PA 19355
• MDR Report Key: 3855850
• MDR Text Key: 21965915
• Report Number: 3855850
• Device Sequence Number: 1
• Product Code: MQV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2013,01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 2101-0010
• Device Lot Number: A1301039
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2014
• Distributor Facility Aware Date: 05/06/2013
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 60