MAUDE Adverse Event Report: ENCORE MEDICAL L.P. COBALT CEMENT; COBALT HV BONE CEMENT 40GM

Model Number	600-15-000
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint - while opening the packaging tore through the sterile pack due to packaging malfunction.

• Brand Name: COBALT CEMENT
• Common Device Name: COBALT HV BONE CEMENT 40GM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8376012
• Report Number: 1644408-2019-00152
• Device Sequence Number: 1780567
• Product Code: LOD
• UDI-Device Identifier: 00190446138006
• UDI-Public: (01)00190446138006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: Health Professional
• Device Model Number: 600-15-000
• Device Catalogue Number: 600-15-000
• Device Lot Number: 730D1D0002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/27/2019
• 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