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

Catalog Number	2101-0005
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Chest Pain (1776); Pain (1994)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5762365
• Report Number: 0002530131-2016-00011
• Device Sequence Number: 10764019
• Product Code: NDN
• UDI-Device Identifier: 00808232000962
• UDI-Public: (01)00808232000962
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 2101-0005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other