MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ORTHOSET I BONE CEMENT

Model Number	14101000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, bone cement was damaged.
Additional Manufacturer Narrative
Not known serious injury as a result of this incident.Please void the initial report.

• Brand Name: ORTHOSET I BONE CEMENT
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10340625
• Report Number: 3010536692-2020-00528
• Device Sequence Number: 1865600
• Product Code: LOD
• UDI-Device Identifier: M684141010001
• UDI-Public: M684141010001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 14101000
• Device Catalogue Number: 14101000
• Device Lot Number: 19W115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/08/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other