MAUDE Adverse Event Report: EBI, LLC. SPINALPAK STIMULATOR, BIOMET; SPINE STIMULATOR

Model Number N/A

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

Patient Problem Neck Stiffness (2434)

Event Type  Injury  

Manufacturer Narrative

Review of the device history records show that the lot was released with no recorded anomaly or deviation.The product was not returned by the patient for an evaluation.Current information is insufficient to permit a valid conclusion about the cause of this event.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

The patient's wife reported the patient is experiencing stiffness in his neck between the shoulder blades and neck.The patient's wife reported that the patient has rheumatoid arthritis.The patient's wife reported the zimmer biomet bone stimulating device is treating the lower back (lumbar spine).The patient's wife reported she called the doctor who advised the patient to take the unit off for four days and see if the stiffness remains.The patient's wife advised she will reach out to the doctor to obtain more pain medication for the patient.It is unknown if the patient received additional pain medication from the request of his wife.Attempts have been made to reach the patient, his wife, or the sales representative to obtain more information.However, the attempts have been unsuccessful and no additional information was able to be obtained.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Type of Device: SPINE 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: 6095593
• MDR Text Key: 59715278
• Report Number: 0002242816-2016-00036
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• 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: 1067717
• Device Lot Number: N/A
• Other Device ID Number: (01)00812301020218(21)L30517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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): Other; Required Intervention