MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	106130-17
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient indicated that she developed a rash and had skin irritation while using orthopak unit.Later, the customer service representative called and patient stated that she wore 72r electrodes with cover patches for 20-22 hours.The patient stated that her skin is sensitive to adhesives and took break from treatment for two week until the skin cleared.Once she started using it again, the rash/ skin irritation developed again.The patient contacted their physician and were advised to switch to bhs unit.No further consequences has been reported.The 72r electrodes and cover patches were not returned for further evaluations.
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 indicated that she developed a rash and had skin irritation while using orthopak unit.Later, the customer service representative called and patient stated that she wore 72r electrodes with cover patches for 20-22 hours.The patient stated that her skin is sensitive to adhesives and took break from treatment for two weeks until the skin cleared.Once she started using it again, the rash/ skin irritation developed again.The patient contacted their physician and were advised to switch to bhs unit.No further consequences has been reported.The 72r electrodes and cover patches were not returned for further evaluations.
Additional Manufacturer Narrative
Corrections in b4: date of the report and d2: common name.Additional information in d4: lot number, expiration date, h4: manufacture date, g3, h6 and h10: additional narrative.Estimated date of the event b3: january 2025.This follow-up report is being submitted to relay additional and corrected information.The cover patches were not returned to (b)(6) 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.(b)(6) medical will continue to monitor trends.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• 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: 21294760
• Report Number: 0002242816-2025-00024
• Device Sequence Number: 9208097
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/24/2025

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 Expiration Date: 07/27/2025
• Device Model Number: 106130-17
• Device Lot Number: 231502
• 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: 02/03/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic