MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM; SPINALPAK STIMULATOR, BIOMET

Model Number	1067717
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow up report will be sent.
Event or Problem Description
It was reported by the sales representative that the patient experienced pain and felt tingling sensation in heel/ shin of his legs.The patient said after he wore the stimulator for 1-2 days and 24hrs he noticed a pain in his buttock and highs.The patient indicated that the pain level was at 9 on a scale of 1-10, 10 being the worst.The patient was concerned that this was due to the stimulator as after he removed the stimulator the sensation improved and went away after a few hours.The sales representative mentioned to the patient that he might try moving the electrodes a little wider from the incisions and see if this improves the sensation.Additionally, the sales representative advised the patient to conduct the time-test.The patient contacted his physician and spoke to the pa who advised him to call (b)(6) medical.No further information has been reported.The spinalpak stimulator has not been returned for evaluation.
Event or Problem Description
It was reported by the sales representative that the patient experienced pain and felt tingling sensation in heel/ shin of his legs.The patient said after he wore the stimulator for 1-2 days and 24hrs he noticed a pain in his buttock and highs.The patient indicated that the pain level was at 9 on a scale of 1-10, 10 being the worst.The patient was concerned that this was due to the stimulator as after he removed the stimulator the sensation improved and went away after a few hours.The sales representative mentioned to the patient that he might try moving the electrodes a little wider from the incisions and see if this improves the sensation.Additionally, the sales representative advised the patient to conduct the time-test.The patient contacted his physician and spoke to the pa who advised him to call (b)(6) medical.As per the follow up call, the patient stated that they are doing the time-test as advised by the sales representative which seems to be helpful as the patient is only experiencing little bit of tingling sensation and has no pain as of now.They have treated up to maximum of 2-3 hours while doing the time-test.The patient has his doctor's appointment on wednesday.The patient will give us a call back if he experiences any issues and after his doctor's appointment or we can follow-up with him.No further information has been reported.The spinalpak stimulator has not been returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical 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.Highridge medical will continue to monitor trends.

• Brand Name: BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
• Common Device Name: SPINALPAK STIMULATOR, BIOMET
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 20577736
• Report Number: 0002242816-2024-00137
• Device Sequence Number: 20856985
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1067717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic