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

Model Number N/A

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient experienced tremendous pain while using the spinal pak device.The patient is not wearing the device.The patient stated that he would not contact the doctor.No additional patient consequences have been reported.

Manufacturer Narrative

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.Zimvie complaint (b)(4).B3: date of event: the event occurred sometime in (b)(6) 2023.D11: medical product: unknown.D11: therapy date: unknown.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE
• 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 07054 ; 9732999300
• MDR Report Key: 16788978
• MDR Text Key: 313758195
• Report Number: 0002242816-2023-00038
• 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
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male