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

Model Number N/A

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

Patient Problem Muscle Spasm(s) (1966)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4) is the manager of r&d for biologics and electrical stimulation for zimmer biomet.She provided the following clinical assessment: "the device is being used for an off label indication." she says the spinalpak is "not approved to treat the cervical spine." her research revealed that, "it is common to have muscle spasms across your neck and even down your arms post-cervical spine fusion.It appears to be a common side effect of cervical fusion." additionally she says, "the symptoms the patient experienced after the anti-spasm medication sound like common side effects.It is likely the medication was making the patient sick, hence the throwing up and since it is anti-spasm medication, it acts on the muscles, and it sounds like it also affected her leg muscles making her feel like her legs were dead." she states that, "the fact that the doctor prescribed the anti-spasm medicine rather than recommending the patient stop using the device is probably due to the fact that he knows muscle spasms is a potential side effect of the cervical fusion procedure itself." she says she doesn't think the patient's symptoms are related to the spinalpak and she doesn't think the surgeon thinks it is either as he continued to recommend she wear the device for twenty-four hours.Review of the device history records show that the lot was released with no recorded anomaly or deviation.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

It is reported that the patient had surgery on the neck at c3 to c5 at the end of april and already had paralysis.The patient states she received the spinalpak on (b)(6) 2016 to treat her neck.It is reported that after one month she began experiencing muscle spasms.The patient reported that she saw her doctor for her symptoms and received anti-spasm medication in the beginning of august.The patient states that three weeks after she received the medication, her legs felt "dead" and she began throwing up.When the patient took the unit off, all was "ok." the doctor advised the patient to continue to wear the device for twenty-four hours.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Type of Device: BONE 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: 6041121
• MDR Text Key: 57860466
• Report Number: 0002242816-2016-00033
• 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
• Type of Report: Initial
• Report Date: 09/21/2016

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067717
• Device Lot Number: N/A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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