MAUDE Adverse Event Report: ACUTE INNOVAITONS LLC BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE; BIOBRIDGE PLATE

Model Number BIOBRIDGE

Device Problem No Apparent Adverse Event (3189)

Patient Problem Missing Value Reason (3192)

Event Date 01/08/2019

Event Type  Injury  

Event Description

Per the surgeon who performed the initial surgery it is understood that the patient had developed seroma, which is not uncommon to develop post surgery.The patient contacted acute with questions regarding "infection" and the plate's nature to withhold.The patient consulted a plastic surgeon rather than the surgeon who performed the initial surgery.The patient had the "infection"/seroma drained by the plastic surgeon and the plates (which were implanted in small pieces in the first place) also got drained.

• Brand Name: BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE
• Type of Device: BIOBRIDGE PLATE
• Manufacturer (Section D): ACUTE INNOVAITONS LLC; 8055 ne jacobson street; suite 700; hillsboro 97124
• Manufacturer (Section G): ACUTE INNOVAITONS LLC; 8055 ne jacobson street; suite 700; hillsboro 97124
• Manufacturer Contact: subash sankar tamilselvan ; 8055 ne jacobson street; suite 700; hillsboro 97124 ; 5036867200
• MDR Report Key: 8391303
• MDR Text Key: 137865052
• Report Number: 3005670412-2019-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10814493010609
• UDI-Public: (01)10814493010609
• Combination Product (y/n): N
• PMA/PMN Number: K120163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BIOBRIDGE
• Device Catalogue Number: RRP1501
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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