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	Bruise/Contusion (1754); Erythema (1840); 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 were able 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
During supply order the patient mentioned that at the beginning of treatment she tried the cover patches on one day only.When she removed the cover patch from her neck the adhesive was very sticky, she could not get the covers off so she had to rip it off quickly like a band-aide and this was very painful and left a red bruise on her skin.The patient assessed the pain at an 8 out of 10 and the pain did not last long.The patient did not speak to her doctor about this event.She continued treating without the cover patches and everything is working well without them.The patient will return one unused cover patch with the pouch provided.No new product was shipped to the patient.Return noted.
Additional Manufacturer Narrative
Additional information: b4- date of this report, g3- date received by manufacturer, h2 ¿ follow up type.Corrected data: d2 ¿ common device name and product code, d4 ¿ model number, catalog number, lot number, expiration date, udi number, h4-device manufacture date.This follow-up report is being submitted to relay additional and corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.The device is used for treatment.Ebi will continue to monitor trends.
Event or Problem Description
During supply order the patient mentioned that at the beginning of treatment she tried the cover patches on one day only.When she removed the cover patch from her neck the adhesive was very sticky, she could not get the covers off so she had to rip it off quickly like a band-aide and this was very painful and left a red bruise on her skin.The patient assessed the pain at an 8 out of 10 and the pain did not last long.The patient did not speak to her doctor about this event.She continued treating without the cover patches and everything is working well without them.The patient will return one unused cover patch with the pouch provided.No new product was shipped to the patient.Return noted.
Event or Problem Description
During supply order the patient mentioned that at the beginning of treatment she tried the cover patches on one day only.When she removed the cover patch from her neck the adhesive was very sticky, she could not get the covers off so she had to rip it off quickly like a band-aide and this was very painful and left a red bruise on her skin.The patient assessed the pain at an 8 out of 10 and the pain did not last long.The patient did not speak to her doctor about this event.She continued treating without the cover patches and everything is working well without them.The patient will return one unused cover patch with the pouch provided.No new product was shipped to the patient.
Additional Manufacturer Narrative
Additional information- b4: date of this report, g3: date received by manufacturer, h6: evaluation codes corrected data ¿ b3, h6: patient code and impact code section b3: as the date of the event is unknown, the event date is estimated as october of 2025.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to ebi 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.The device is used for treatment.Ebi 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: 23983554
• Report Number: 0002242816-2026-00161
• Device Sequence Number: 10703928
• Product Code: LOF
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2026

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: Other
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 25F170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 67 YR
• Patient Sex: Unknown