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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient had surgery on the cervical area.The patient stated that she is feeling loss of energy and the bones are sore.The patient stated that she feels very tired and the body is aching.The patient has not used the bone growth stimulator for the back in two days.The patient is hurting.The pain is below the skin.The patient has a lot of neck and back pain.The patient stated that she feels like tingling going down the back to her legs and toes and arms.The patient rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient had the pain prior to using the stimulator.The patient has increased her daily activity a little bit.The patient did not speak to the doctor, and stopped using the unit and she is feeling a little bit stronger.Patient was told not to use the unit until she speaks to her surgeon.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.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.

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 burning sensation and 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.

Event Description

It was reported that the patient had surgery on the cervical area.The patient stated that she is feeling loss of energy and the bones are sore.The patient stated that she feels very tired and the body is aching.The patient has not used the bone growth stimulator for the back in two days.The patient is hurting.The pain is below the skin.The patient has a lot of neck and back pain.The patient stated that she feels like tingling going down the back to her legs and toes and arms.The patient rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient had the pain prior to using the stimulator.The patient has increased her daily activity a little bit.The patient did not speak to the doctor, and stopped using the unit and she is feeling a little bit stronger.Patient was told not to use the unit until she speaks to her surgeon.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINALPAK, 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, NJ 07054 ; 9732999300
• MDR Report Key: 12784133
• MDR Text Key: 283161098
• Report Number: 0002242816-2021-00195
• 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: 04/11/2023

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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female