MAUDE Adverse Event Report: ACUTE INNOVATIONS, LLC RIBLOC U PLUS; RIBLOC U PLUS 75MM RIB PLATE

Model Number	RIBLOC U PLUS
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Plate removal due to adhesions under scapula from scar tissue of incision.Ribs were healed during removal and removal was done without issue in (b)(6) 2016.

• Brand Name: RIBLOC U PLUS
• Common Device Name: RIBLOC U PLUS 75MM RIB PLATE
• Manufacturer (Section D): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• MDR Report Key: 6497032
• Report Number: 3005670412-2017-00001
• Device Sequence Number: 557506
• Product Code: HRS
• UDI-Device Identifier: 10814493010388
• UDI-Public: 10814493010388
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2017

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: Health Professional
• Device Model Number: RIBLOC U PLUS
• Device Catalogue Number: RBL1302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/17/2017
• 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