MAUDE Adverse Event Report: ACUTE INNOVATIONS BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE; PLATE, FIXATION, BONE

Model Number	RRP1501
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient came in who suffered 5 rib fractures (numbers 4,5,6,7,8).Four biobridge plates were used to fixate two of the five ribs (numbers 7 and 8) as there were significant gaps in his chest wall from the fractures.The remaining 3 ribs were fixed with ribloc uplus plates and screws.A week later the patient was booked again for surgery as both doublets of biobridge had snapped.Root cause is difficult to determine.Biobridge plates can be installed in a wide variety of configurations.They can be preformed and sutured to the bone in a wide variety of methods.It is difficult to determine what exactly went wrong with the particular construct that was used for this particular patient.Additionally, one of the contraindications for use as stated in the technique is "insufficient quantity or quality of bone/soft tissue," (rrp600 rev i effective (b)(6) 2018).
Event or Problem Description
Patient came in who suffered 5 rib fractures (numbers 4,5,6,7,8).Four biobridge plates were used to fixate two of the five ribs (numbers 7 and 8) as there were significant gaps in his chest wall from the fractures.The remaining 3 ribs were fixed with ribloc uplus plates and screws.A week later the patient was booked again for surgery as both doublets of biobridge had snapped.

• Brand Name: BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUTE INNOVATIONS; 8055 ne jacobson street; suite 700; hillsboro OR 97124 9374
• MDR Report Key: 10260875
• Report Number: 3005670412-2020-00003
• Device Sequence Number: 2301860
• Product Code: HRS
• UDI-Device Identifier: 10814493010609
• UDI-Public: 10814493010609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: RRP1501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/10/2020
• 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: 62 YR
• Patient Weight: 113