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

Model Number	RBL1301
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2016, five rib plates were successfully implanted to treat rib fractures.The patient developed an infection and all five plates were removed on (b)(6) 2016.Plates were not returned for investigation.

• Brand Name: RIBLOC U PLUS 50MM RIB PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• MDR Report Key: 5880990
• Report Number: 3005670412-2016-00006
• Device Sequence Number: 13585256
• Product Code: HRS
• UDI-Device Identifier: 10814493010371
• UDI-Public: 10814493010371
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: RBL1301
• Device Catalogue Number: RBL1301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 08/16/2016
• 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