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

Model Number	1082020
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	03/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial mdr was submitted on 07 apr 2016 with the incorrect manufacturer report number of 3010203-2016-00001.
Event or Problem Description
It was reported by the doctor that ectopic ossification emerged after start of therapy in the treatment area for approximately two weeks.The causal opinion is deemed possibly related because the callus is made and causation cannot be denied completely.The patient has stopped using the device and etidronate disodium is being administered.Attempts for additional for additional information has been unsuccessful up to date.

• Brand Name: EXOGEN ULTRASOUND BONE HEALING SYSTEM
• Common Device Name: EXOGEN
• Manufacturer (Section D): BIOVENTUS, LLC; 1900 charles bryan road; suite 275; cordova TN 38016
• Manufacturer (Section G): BIOVENTUS LLC; 1900 charles bryan road; suite 275; cordova TN 38016
• Manufacturer Contact: amanda dieck ; 1900 charles bryan road; suite 275; cordova, TN 38016 ; 9013412976
• MDR Report Key: 5640824
• Report Number: 3010203571-2016-00001
• Device Sequence Number: 19746960
• Product Code: LOF
• UDI-Device Identifier: 00816986020808
• UDI-Public: 00816986020808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: Lay User/Patient
• Device Model Number: 1082020
• Device Catalogue Number: 71034640
• Device Lot Number: 10DM07835
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2016
• Supplement Date Received by Manufacturer: 03/29/2016
• Initial Report FDA Received Date: 05/09/2016
• Supplement Report FDA Received Date: 05/09/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female