MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES AND COVER PATCHES)

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: synthes peek cage.Therapy date: unknown.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient states developed blisters and sores all over his neck from 72r electrodes and the cover patches.The patient states that his skin irritation started about 4 days ago on the cervical area.The patient has been using the electrodes and cover patches.He described his skin as red, itchy with scaly blisters.The blisters are hard to the touch and scaly.The irritation is the size of the cover patches.The electrodes and cover patches were changed every 2 to 3 days, they were rotated every day.The area is clean with soap and water.The patient does not have sensitive skin, allergies nor takes any blood pressure medication.The patient spoke with the doctor's office who told him to contact the zimmer biomet and to use neosporin.The patient was sent replacement 63b electrodes.

Event Description

It was reported that the patient states developed blisters and sores all over his neck from 72r electrodes and the cover patches.The patient states that his skin irritation started about 4 days ago on the cervical area.The patient has been using the electrodes and cover patches.He described his skin as red, itchy with scaly blisters.The blisters are hard to the touch and scaly.The irritation is the size of the cover patches.The electrodes and cover patches were changed every 2 to 3 days, they were rotated every day.The area is clean with soap and water.The patient does not have sensitive skin, allergies nor takes any blood pressure medication.The patient spoke with the doctor's office who told him to contact the zimmer biomet and to use neosporin.The patient was sent replacement 63b electrodes.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES AND COVER PATCHES)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12330185
• MDR Text Key: 266835965
• Report Number: 0002242816-2021-00141
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• 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,Followup
• Report Date: 05/03/2023

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: 108101, 031440
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male