MAUDE Adverse Event Report: BIOVENTUS LLC / EXOGEN STIMULATOR, INVASIVE BONE GROWTH

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Description of event: the patient reported that their ¿bone stimulator/ osteogenesis stimulator¿ was not working.The patient stated that ¿it¿s like an ultrasound thing¿.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, INVASIVE BONE GROWTH
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): BIOVENTUS LLC / EXOGEN; 7101 goodlett farms pkwy.; cordova TN 38016
• MDR Report Key: 17653327
• MDR Text Key: 322404243
• Report Number: MW5145083
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Patient Sequence Number: 1