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

Catalog Number 2101-0005

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problems Chest Pain (1776); Pain (1994)

Event Date 05/26/2016

Event Type  Injury  

Event Description

It was reported that; sales rep was advised that patient reported chest pain after product was used.Went into er 3 days after case.Rep reported that cortoss had a great fill under xray.A pulmanogist examined patient, suggested ct that be done.Ct shows that cement leaked toward lung.

Manufacturer Narrative

Method: risk assessment; results: device history review, device evaluation, complaint history review and medical records review could not be performed as no items were provided.Conclusion: the exact root cause of the reported event could not be determined as no device and/or insufficient information was provided for review.

Event Description

It was reported that; sales rep was advised that patient reported chest pain after product was used.Went into er 3 days after case.Rep reported that cortoss had a great fill under xray.A pulmonologist examined patient, suggested ct that be done.Ct shows that cement leaked toward lung.

• Brand Name: 5CC 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5762365
• MDR Text Key: 48574278
• Report Number: 0002530131-2016-00011
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00808232000962
• UDI-Public: (01)00808232000962
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2101-0005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2016
• 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