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

Model Number RIBLOC U PLUS

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Scar Tissue (2060)

Event Date 02/27/2017

Event Type  Injury  

Event 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
• Type of Device: RIBLOC U PLUS 75MM RIB PLATE
• Manufacturer (Section D): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• Manufacturer (Section G): ACUTE INNOVATIONS, LLC; 21421 nw jacobson road; suite 700; hillsboro OR 97124
• Manufacturer Contact: veronica caldwell ; 21421 nw jacobson road; suite 700; hillsboro, OR 97124
• MDR Report Key: 6497032
• MDR Text Key: 72903963
• Report Number: 3005670412-2017-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10814493010388
• UDI-Public: 10814493010388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RIBLOC U PLUS
• Device Catalogue Number: RBL1302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention