MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS 10CC CARTRIDGE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number 21010000SSP

Device Problems Shelf Life Exceeded (1567); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

It was reported that; issue was identified during billing.Unit used in this case had an expiry date of (b)(6) 2015.The patient is doing fine.

Manufacturer Narrative

Method: device history review.Results: device history review indicated all devices accepted into final stock met specifications.Device evaluation could not be performed as no items were returned.Complaint history review indicated there have been no other similar complaints for the reported lot.Conclusion: the most likely cause of the reported event was determined to be user error.

Event Description

It was reported that; issue was identified during billing.Unit used in this case had an expiry date of april 30, 2015.The patient is doing fine.

• Brand Name: CORTOSS 10CC CARTRIDGE
• 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: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5039001
• MDR Text Key: 25235777
• Report Number: 0002530131-2015-00017
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21010000SSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2012
• 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