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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

The contraindications for the device state "under certain conditions, electromagnetic stimulation generated by a bone healing system could inhibit the output of some demand pacemakers or implantable defibrillators.Therefore, it is not recommended for patients with certain types of pacemakers or implantable defibrillators.Patients should be cautioned to avoid coming in close proximity to pacemaker or defibrillator wearers during stimulation treatment." without a product return, no product evaluation is able to be conducted.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

On (b)(6) 2016 the patient reported the following: he has been having chest pains for several days.He stated he has not sought medical treatment.He has been treating 20 hours a day.He has had a big weight gain since (b)(6) which was (b)(6).Patient was advised to contact his cardiac doctor.On (b)(6) 2016 the patient stated he was doing fine and has not been using the stimulator, and the pain went away the day following his complaint.On (b)(6) 2016 it was reported the patient was doing fine and has seen his cardiologist.He will be treated using the orthopak unit.

Manufacturer Narrative

The device history record was reviewed and no non-conformances were identified that would cause or contribute to the reported event.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: NON-INVASIVE BONE GROWTH 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: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 5538511
• MDR Text Key: 41568390
• Report Number: 0002242816-2016-00010
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP790002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• 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
• Other Device ID Number: (01)00812301020560(21)D30950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 100