MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; NON INVASIVE BONE HEALING STIMULATOR

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Neck Stiffness (2434)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: april 29, 2022.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported by the sales rep that the patient's unit is not holding a charge.Per patient phone call, the controller is not charging and not registering the patient's treatments.No symbols are on screen to alert any issues.The controller can be charged overnight and show two bars, then when turned on for treatment, the bars drop to one bar and the unit turns off.The charger continues to remain orange and does not turn to green anymore.The patient switched outlets and rooms to charge, and neither helped.The patient claims the unit was not dropped or in contact with any liquid.The wires were not snagged, and there were no exposed wires.The patient will return the bhs controller.Per the patient, she also reported a "zinging pain" when she treats.The patient associated the pain with healing since (b)(6) 2022, but when she mentioned pain to her rep today, the rep asked her to report the pain to customer service.The patient claims the "zinging pain" begins about one hour after she begins treating.The pain is an 8 on a scale from 1 to 10.The patient also describes a "stiffness" that accompanies the pain.The patient reports that the pain continues approximately 5 hours after she is finished with the treatment.The patient reported that she saw her doctor who told her to stop using the unit because it was not yielding any positive results in regards to her bone growth and due to the discomfort she experienced with the product.The patient stated that the doctor did not prescribe anything.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: NON INVASIVE BONE HEALING STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: tanisha tucker ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 14444818
• MDR Text Key: 292211013
• Report Number: 0002242816-2022-00047
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020560
• UDI-Public: 00812301020560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068234
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female