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

Model Number	RIBLOC U PLUS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was plated (b)(6) 2016 to treat 3 broken ribs from a horseback riding accident.On 08/08/2017 the sales rep notified acute that xray films showed that 2 of the 3 plates had broken and revision surgery was planned.It is unknown when the first plate broke, the second plate broke (b)(6) 2017.It was stated in the medical history that the patient fell at some unknown time after the initial surgery.Details of the fall are not provided.Plates returned were inspected, the ends of the breaks for both plates were rubbed smooth which indicates that the plates fractured and rubbed together for an unknown significant amount of time.Both plates met print specifications.The broken ribs were replated.All screws used to secure the plate were returned - 8 in all- these showed normal wear for installation and removal of plate.Report 2 of 2.

• Brand Name: RIBLOC U PLUS
• Common Device Name: RIBLOC U PLUS 75MM PLATE
• Manufacturer (Section D): ACUTE INNOVATIONS LLC; 21421 nw jacobson rd; suite 700; hillsboro OR 97124 9374
• MDR Report Key: 6872969
• Report Number: 3005670412-2017-00014
• Device Sequence Number: 1404589
• Product Code: HRS
• UDI-Device Identifier: 10814493010388
• UDI-Public: 10814493010388
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: RIBLOC U PLUS
• Device Catalogue Number: RBL1302
• Device Lot Number: L1401065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/18/2017
• 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: 55 YR
• Patient Weight: 59