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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.A review of the device history records show the device 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

The patient's wife reported the following: patient is experiencing pain.Patient received his spinalpak in (b)(6) 2015 but he did not start using it until (b)(6) 2016.After eight (8) days he was experiencing severe pain like sciatica from hip to knee.His l2 is the site being treated.He was taken to the hospital and was given percoset and anti-inflammatories.The pain was worse and he spoke with his doctor in the middle of (b)(6) 2016 who told him to remove the stimulator which he did.On friday, (b)(6) 2016, the patient went for a nerve block.He was sore on (b)(6) 2016 and the next day, sunday (b)(6) 2016.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: 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: 5489759
• MDR Text Key: 39988132
• Report Number: 0002242816-2016-00003
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/10/2016

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: 1067716
• Device Lot Number: N/A
• Other Device ID Number: (01)00888480547903(21)L14794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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