MAUDE Adverse Event Report: ACUTE INNOVATIONS RIBLOC® U PLUS CHEST WALL PLATING SYSTEM; PLATE, FIXATION, BONE

Model Number	RBL1302
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was complaining of discomfort/pain and requested plate removal.Date of initial surgery was (b)(6) 2020.Date of removal surgery was (b)(6) 2020.Screws were removed and then the plate was removed.During the removal surgery both posterior clamps broke.Plate was not broken before removal.One was removed and one was left in situ.Surgeon did not express concern about leaving the posterior aspect of plate in patient.The 75mm rib plate had been installed for approximately 18 weeks.Bone healing usually takes about 12 weeks.The doctor did not give any indication that the bone did not heal or that the plate did not perform as expected.The plate was not broken before the surgery.There was also no indication about an infection.Based on the information supplied the plate functioned properly in allowing the bone to heal.The cause for discomfort/pain was not believed to be related to the implant.Risks related to implant breakage during removal have been evaluated.Although the root cause is unknown, if the surgeon had trouble removing the fragment because of bony growth around the plate he may have chosen to leave it in place instead of disturbing the bone and possibly refracturing the rib trying to remove the remaining fragment.
Event or Problem Description
Patient was complaining of discomfort/pain and requested plate removal.Date of initial surgery was (b)(6) 2020.Date of removal surgery was (b)(6) 2020.Screws were removed and then the plate was removed.During the removal surgery both posterior clamps broke.Plate was not broken before removal.One was removed and one was left in situ.Surgeon did not express concern about leaving the posterior aspect of plate in patient.

• Brand Name: RIBLOC® U PLUS CHEST WALL PLATING SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUTE INNOVATIONS; 8055 ne jacobson street; suite 700; hillsboro OR 97124 9374
• MDR Report Key: 10072203
• Report Number: 3005670412-2020-00002
• Device Sequence Number: 666481
• Product Code: HRS
• UDI-Device Identifier: 10814493010388
• UDI-Public: 10814493010388
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K113318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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: RBL1302
• Device Catalogue Number: RBL1302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/19/2020
• 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: Other
• Patient Age: 54 YR