MAUDE Adverse Event Report: ACUTE INNOVATIONS LLC PLATE, FIXATION, BONE

Device Problems Break (1069); Crack (1135); Fracture (1260); Nonstandard Device (1420)

Patient Problems Internal Organ Perforation (1987); Respiratory Distress (2045)

Event Date 08/01/2017

Event Type  Injury  

Event Description

Caller stated in (b)(6) 2016 she had bone plates implanted to treat her rib injury.In (b)(6) 2017 she began to experience breathing issues caused by a crack in one of the rib plates.One week later, a second plate fractured and punctured her lung causing her to have emergency surgery to remove and replace the device.In (b)(6) 2018, one of the replacement plates broke and was surgically removed.Caller found that acute innovations had a recall for rib plates in the past and would like these models to be removed from sale.When she reported her issue to the manufacturer, she was told that the device is temporary and lasts 6 months.

• Brand Name: PLATE, FIXATION, BONE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUTE INNOVATIONS LLC
• MDR Report Key: 7269549
• MDR Text Key: 100174305
• Report Number: MW5075220
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/13/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization