MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; SPINAL PAK NON-INVASIVE STIMULATOR

Model Number N/A

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

Patient Problems Nausea (1970); Pain (1994); Skin Burning Sensation (4540)

Event Type  Injury  

Event Description

Patient started having pain, burning and nausea after putting on device it was reported by that the patient experienced pain, burning, and nausea while treating with the device.The patient received the spinal pak assembly on (b)(6) 2021 and immediately started having pain, burning, and nausea.This feeling continued through (b)(6), when she decided to take it off.The patient was encouraged to take a break over the next few days and try it again for an hour a day and do a slow work-up.It was later reported on that the patient was advised by her physician to discontinue treatment.It was reported that no further information is available.

Manufacturer Narrative

The device was returned to zimmer biomet and the investigation is complete.The reported event was not verifiable after the investigation associated with pain, burning and nausea.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 review of 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.Zimmer biomet will continue to monitor for trends.Zimmer biomet (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device not was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with pain.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.The following sections have been updated: b4: date of this report added.D3: manufacturer updated.G1-2: contact office updated.G3: date received by manufacturer added.G6: type of report updated.H2: follow up type added.H3: device evaluated by manufacturer updated to no.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

Patient started having pain, burning and nausea after putting on device it was reported by that the patient experienced pain, burning, and nausea while treating with the device.The patient received the spinal pak assembly on (b)(6) 2021 and immediately started having pain, burning, and nausea.This feeling continued through (b)(6) 2021, when she decided to take it off.The patient was encouraged to take a break over the next few days and try it again for an hour a day and do a slow work-up.It was later reported on that the patient was advised by her physician to discontinue treatment.It was reported that no further information is available.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR
• 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: 12969040
• MDR Text Key: 283309193
• Report Number: 0002242816-2021-00224
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• 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: 10/20/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2021
• 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: Female