MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 10CC CARTRIDGE; CORTOSS

Catalog Number 2101-0010

Device Problem Occlusion Within Device (1423)

Patient Problems Muscle Spasm(s) (1966); Tingling (2171)

Event Date 07/14/2014

Event Type  Injury  

Event Description

It was reported that a patient was treated for a multi-level instrumented fusion from l2-s1 following a diagnosis of spondylosis.Cortoss was used to augment pedical screws due to surgeons concerns about the patients osteopaenic bone.The patient presented tingling in her toes and hands which was progressing 10 days post operation.Patient was admitted to the hospital with a diagnosis of guillain-barre syndrome causing respiratory muscle spasm which required ventillation.During this time, the patient required x-ray images and cts of the chest where the emoblization of cortoss was identified in the right pulmonary artery.

Manufacturer Narrative

Through conversation with the operating surgeon, dr.(b)(6), it was concluded at the time the images were reviewed there was no evidence of material in the lung.Dr.(b)(6) also consulted with a thoracic surgeon for advice.It was determined that given the lack of symptoms, the clinical plan is to treat the patient with anticoagulation to endothelialise the cortoss.A review of the cortoss us pivotal clinical study was performed.There were no adverse events attributed to pulmonary embolism.Further, there is no literature that associates cortoss with pulmonary embolisms but rather pmma.Lot specific information was not made available to review the device history record.Device implanted into patient, product lot information not made available by user facility.

• Brand Name: 10CC CARTRIDGE
• Type of Device: CORTOSS
• 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: jeremy apelian ; 45 great valley parkway; malvern, PA 19355 ; 6104075257
• MDR Report Key: 3973647
• MDR Text Key: 4629786
• Report Number: 0002530131-2014-00013
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080108
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2101-0010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• 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