MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; SPINALPAK NONINVASIVE BONE GROWTH STIMULATOR

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021.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.

Event Description

It was reported by the sales rep that the patient started using the stimulator, and since using it, he has had an increase in pain.The patient states that the pain is to the left of his incisional area, and it is a stabbing pain.The patient stated the pain level was a 10 out of 10.They stated they had not increased daily activity and has not talked to their doctor.The patient was initially wearing the unit 24 hours a day.The patient was advised to call the doctor and to not wear the unit the next day.They were told to wear the unit for only two hours the following day and see if they were still in pain.If not, they can add an hour each day to build up to a full day and see if that helps.The patient said they have not been getting pain since doing the time test.They did not take any medication for pain related to the unit.They were previously prescribed hydrocodone for pain 6 months ago.

Event Description

It was reported by the sales rep that the patient started using the stimulator, and since using it, he has had an increase in pain.The patient states that the pain is to the left of his incisional area, and it is a stabbing pain.The patient stated the pain level was a 10 out of 10.They stated they had not increased daily activity and has not talked to their doctor.The patient was initially wearing the unit 24 hours a day.The patient was advised to call the doctor and to not wear the unit the next day.They were told to wear the unit for only two hours the following day and see if they were still in pain.If not, they can add an hour each day to build up to a full day and see if that helps.The patient said they have not been getting pain since doing the time test.They did not take any medication for pain related to the unit.They were previously prescribed hydrocodone for pain 6 months ago.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The device was not returned to zimvie for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.D9: device availability added.G1: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow-up type updated.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: type of device code updated to 2993: adverse event without identified device or use problem.H6: type of investigation updated to 3331: analysis of production records.H6: type of investigation updated to 4114: device not returned.H6: type of investigation updated to 4119: insufficient information available.H6: investigation findings updated to 3221: no findings available.H6: investigation conclusions updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINALPAK NONINVASIVE BONE GROWTH STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; 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: 12915345
• MDR Text Key: 281587617
• Report Number: 0002242816-2021-00210
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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: Male