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

Model Number N/A

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported the patient is complaining pain while using the spinal pak unit, though he has not worn it for a straight 24 hours yet.The patient stated that the pain is below his skin, it feels like his muscles are knotting up.The patient stated that the pain is a constant irritation that gradually builds up after eight or nine hours of use and that the muscles in his upper back and neck feel extremely knotted and he feels "literally nauseous." the patient stated that it takes 2 or 3 days for him to recover from the pain.The patient rated the pain as 10 on a scale of 1 to 10, with 10 being the highest.The patient stated he has not increased his daily activity recently.The patient has stopped treating with the product.The patient stated he has been taking many pain killers prior to using the spinal pak.It was later reported the patient saw the physician's assistant and not the doctor.The physician's assistant did not discuss any treatment for the pain he is having, nor did they discuss further treatment with the spinal pak.The patient said he "assumes'" he will resume treating with the new spinal pak.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 13547027
• MDR Text Key: 285732251
• Report Number: 0002242816-2022-00014
• 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: 02/16/2022

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: 01/18/2022
• Initial Date FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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