MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE UNITE; PLATE, MEDIAL COLUMN TNCM, LONG, LEFT

Model Number	MPP8602L
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the end user that on (b)(6) 2021 he had surgery to remove a broken plate.End user reported, "the plate in his leg had broken sometime between 8/11/2020 and 11/20/2020".No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported the end user he had to have surgery to remove a broken plate.

• Brand Name: MEDLINE UNITE
• Common Device Name: PLATE, MEDIAL COLUMN TNCM, LONG, LEFT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11506142
• Report Number: 1417592-2021-00031
• Device Sequence Number: 11627915
• Product Code: HRS
• UDI-Device Identifier: 10888277691254
• UDI-Public: 10888277691254
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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: MPP8602L
• Device Catalogue Number: MPP8602L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/17/2021
• 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: Required Intervention
• Patient Age: 44 YR
• Patient Weight: 128