MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; ELECTRODE COVER PATCHES

Model Number	106130-17
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
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 patient that the cover patches ripped out his hair and took off skin when removed.The patient contacted their physician and were advised to stop treating.No further information has been reported.The cover patches have not been returned for evaluation.
Event or Problem Description
It was reported by the patient that the cover patches ripped out his hair and took off skin when removed.The patient contacted their physician and were advised to stop treating.No further information has been reported.The cover patches have been returned for evaluation.
Additional Manufacturer Narrative
Corrections in h6: device evaluation codes.
Event or Problem Description
It was reported by the patient that the cover patches ripped out his hair and took off skin when removed.The patient contacted their physician and were advised to stop treating.No further information has been reported.The cover patches have been returned for evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer, g1: contact office, g6: type of repor.Additional information in d4: lot number (301316 & 306985), expiration date, h4: device manufacture date (for lot number 306985- 3/30/2023), h6: component, investigation type, findings, and conclusions.Investigation summary: the cover patches were received for evaluation.The dhrs were reviewed for both lot numbers 301316 & 306985.A visual inspection of the customer¿s returned product was performed.Included was two packs of cover patch's part no.106130-17 with lot no.301316 & 306985 received in a shipping mailer cushion envelope.The parts received look to be in good condition from the visual/cosmetic view.The certificate of conformance was requested and reviewed in the product information section and there were no non-conformances or deviations reported.Review of complaint history identified (126) total complaints from (aug 5, 2023) to (aug 5, 2024) for pn (106130-17) and events related to (electrode irritation/rash).Keyword search criteria: (complaint codes: electrode: irritation; electrode: rash).The search was specified to lot no.306985.The search identified 1 complaint.The search was specified to lot no.301316.The search identified 1 complaint.A review of the information provided by the customer and along with the findings from the investigation, indicate there are no systemic issues with the product or lot.Therefore, the bill of materials (boms), material certifications, master labels, and product drawings were not requested or pulled during this investigation.The approved suppliers were not contacted, and the product was not pulled from stock for evaluation.No physical and/or functional condition could be found after review of the certificate of conformance that could be considered a causal factor for the reported complaint.The reported claim could be associated with a side effect/clinical condition of the patient which is unknown.The reported condition is related to clinical factors beyond the scope of the device investigation covered in the complaint investigation as part of the manufacturing review.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODE COVER PATCHES
• 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: 20088890
• Report Number: 0002242816-2024-00111
• Device Sequence Number: 20786257
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 01/26/2025

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: 11/27/2024
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 301316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 01/27/2025; 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic