MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS 5CC OUS; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number 2101-0002

Device Problems Leak/Splash (1354); Delivery System Failure (2905)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2015

Event Type  malfunction  

Event Description

It was reported that: cement leakage occured while trying augmentation of a pedicle screw.Another cement was available to complete the procedure successfully.

Manufacturer Narrative

Method: device not returned; results: device history review indicated all devices accepted into final stock met specifications.Conclusion: the plausible root cause for the reported event is multifactorial.

Event Description

It was reported that; cement leakage occured while trying augmentation of a pedicle screw.Another cement was available to complete the procedure successfully.

• Brand Name: CORTOSS 5CC OUS
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5345261
• MDR Text Key: 35453490
• Report Number: 0002530131-2016-00002
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: K080108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2101-0002
• Device Lot Number: A1502019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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