MAUDE Adverse Event Report: ACUTE INNOVATIONS, LLC RIBLOC U PLUS; RIBLOC U PLUS 50MM RIB PLATE

Model Number	RBL1302
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Sepsis (2067); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient developed sepsis and plate became detached.Revision surgery performed to treat infection and remove 3 plates.Patient was re-plated with anterior rib plates.Report 3 of 3.

• Brand Name: RIBLOC U PLUS
• Common Device Name: RIBLOC U PLUS 50MM RIB PLATE
• Manufacturer (Section D): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• MDR Report Key: 6522680
• Report Number: 3005670412-2017-00005
• Device Sequence Number: 531139
• Product Code: HRS
• UDI-Device Identifier: 10814493010371
• UDI-Public: 10814493010371
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K113318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

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?: No
• Operator of Device: Physician
• Device Model Number: RBL1302
• Device Catalogue Number: RBL1302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/26/2017
• 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: 61 YR