MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS 10CC OUS; CORTOSS BONE AUGMENTATION MATERIAL

Catalog Number 2101-0000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported, that whilst in surgery the cortoss cement was injected through the delivery unit into the mantis augmentable screw.The customer has reported that instead of the cement going through the fenestrations of the screw and sitting outside the screw, the cement carried on moving through the vertebral body out of the anterior wall.The customer reported that the cement allegedly got into the patient's blood vessel and into the ivc.Resulting from this, the patient was put on warfarin.It was believed the surgeon that the reported event occurred due to the patient having severe osteoporosis which results in the patient's poor bone quality and having large veins.The sales rep reported that no delay to surgery was encountered due to the reported event and that there were no devices to be returned for investigation as they were either implanted or discarded.Finally, the sales rep has reported that the surgery ws completed successfully and that the patient's spine was stable after the surgery.

Manufacturer Narrative

Device used and discarded, lot information not provided.

• Brand Name: CORTOSS 10CC OUS
• Type of Device: CORTOSS BONE AUGMENTATION MATERIAL
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: laura uboh ; 45 great valley parkway; malvern, PA 19355 ; 6104075257
• MDR Report Key: 4495988
• MDR Text Key: 5533497
• Report Number: 0002530131-2015-00001
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2101-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• 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): Other