MAUDE Adverse Event Report: BIOVENTUS, LLC EXOGEN ULTRASOUND BONE HEALING SYSTEM

Catalog Number 71034480

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Lymphoma (3263)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

The device was evaluated by the distributor and found to have 2000 minutes of operating time and no device issues.Based on the timeline of exogen treatment and diagnosis of malignant lymphoma, there is no causal relationship between exogen treatment and the malignant lymphoma diagnosis.The worsening or "increase" of a pre-existing malignant lymphoma by low-intensity pulsed ultrasound is highly unlikely.In general, ultrasound is not known to cause any ontoward effects on tumor development and specifically, there is no evidence in the literature that lupus has any tumor causing or promoting qualities.

Event Description

It was reported by the distributer on 03 aug 2018 that the patient had an "increase in malignant lymphoma." upon follow up, it was reported that the patient began exogen treatment on (b)(6) 2018, was diagnosed with malignant lymphoma on (b)(6) 2018, and discontinued exogen treatment in (b)(6) 2018.As of (b)(6) 2018, the patient was hospitalized for malignant lymphoma.The device evaluation by the distributor showed 2000 minutes of operating time and no device issues.

Event Description

Additional information was received on 19 sep 2018 that stated that the patient was diagnosed with malignant lymphoma on (b)(6) 2018 with a left femoral tumor.The tumor was found after the fracture, it is not known whether the malignant lymphoma is primary or secondary.It was reported that it was a fresh fracture and was not a pathological fracture.As of (b)(6) 2018, the patient remained hospitalized for left femoral tumor.

• Brand Name: EXOGEN ULTRASOUND BONE HEALING SYSTEM
• Type of Device: EXOGEN
• Manufacturer (Section D): BIOVENTUS, LLC; 1900 charles bryan road; suite 275; cordova TN 38016
• MDR Report Key: 7829443
• MDR Text Key: 118650025
• Report Number: 3010203571-2018-00003
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• PMA/PMN Number: P900009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71034480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR