MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; 20" LEAD WIRES, REPLACEMENT

Model Number	1067724-2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
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 that the patient was experiencing pain from the lead wire pressing up against her skin inside of her orthopedic boot.The patient stated that the lead wire split up the middle and became disorganized within her boot, leading to more wires pressed up against her skin.It was later reported that the patient was switched from an orthopak to a spinalpak device.
Additional Manufacturer Narrative
Section b3: as the onset date of the pain is unknown, the event date is estimated as 2024.Corrected data in the following sections: b2, b5, d4: lot number, h4: device manufacture date, h6: impact code, additional information: b4, g3, h6: evaluation codes.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 for trends.
Event or Problem Description
It was reported that the patient was experiencing pain from the lead wire pressing up against her skin inside of her orthopedic boot.The patient stated that the lead wire split up the middle and became disorganized within her boot, leading to more wires pressed up against her skin.The patient was sent a warranty spinalpak unit because the orthopak unit was at end of operation.No further consequences or further information was received.The lead wire was not returned for further evaluation.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: 20" LEAD WIRES, REPLACEMENT
• 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: 20633563
• Report Number: 0002242816-2024-00146
• Device Sequence Number: 12639142
• Product Code: LOF
• UDI-Device Identifier: 00812301020300
• UDI-Public: 00812301020300
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• 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): 04/20/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1067724-2
• Device Catalogue Number: 1067724-2
• Device Lot Number: 2316
• 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: 11/07/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic