MAUDE Adverse Event Report: ACUTE INNOVATIONS LLC RIBLOC U PLUS RIB PLATE

Model Number	RIBLOC U PLUS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was plated approximately one year prior.Patient complained of limited function due to previous rib surgery.Surgeons determined plating cause of limited function.Two plates removed.Report 2 of 2.

• Brand Name: RIBLOC U PLUS RIB PLATE
• Common Device Name: RIB PLATE
• Manufacturer (Section D): ACUTE INNOVATIONS LLC; 8055 ne jacobson st; suite 700; hillsboro OR 97124 9374
• MDR Report Key: 7778535
• Report Number: 3005670412-2018-00006
• Device Sequence Number: 1258618
• Product Code: HRS
• UDI-Device Identifier: 10814493010388
• UDI-Public: 10814493010388
• Combination Product (Y/N): N
• PMA/510(K) Number: K113318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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): Initial
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 08/13/2018
• 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: 54 YR
• Patient Weight: 107