MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; ELECTRODES, 63B, SPINALPAK/ORTHOPAK

Model Number	106130-22
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced irritation and a rash after 2 days of treating with the 63b electrodes.The patient further advised that she did not conduct the time test when changing to the 63b electrodes.The customer service representative advised to conduct the time test and report back to customer service if there are any issues.The patient stated the 63b electrodes also caused a rash.The patient saw the doctor and was prescribed a cream for the irritation.The doctor told her to call zimvie.The patient stated she told the doctor she was going to let her skin heal and try again.The patient stated she wore 63b electrodes for one hour the first day and two hours the next day.The patient stated her skin immediately was irritated.The patient was advised by a zimvie customer service representative to stop wearing the electrodes until her skin completely healed.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore 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.
Additional Manufacturer Narrative
Corrections - b2: required intervention, b4 date of this report added, b5: updated the product was not returned for evaluation, d3 manufacturer email address, g1: contact office and manufacturer site, g6 type of report, h6 method.Additional information - d4: lot number, h4: device manufacture date, h6: investigation type, findings, and conclusions, h10: additional narrative, h11.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 experienced irritation and a rash after 2 days of treating with the 63b electrodes.The patient further advised that she did not conduct the time test when changing to the 63b electrodes.The customer service representative advised to conduct the time test and report back to customer service if there are any issues.The patient stated the 63b electrodes also caused a rash.The patient saw the doctor and was prescribed a cream for the irritation.The doctor told her to call zimvie.The patient stated she told the doctor she was going to let her skin heal and try again.The patient stated she wore 63b electrodes for one hour the first day and two hours the next day.The patient stated her skin immediately was irritated.The patient was advised by a zimvie customer service representative to stop wearing the electrodes until her skin completely healed.The 63b electrodes were not returned for evaluation.
Event or Problem Description
It was reported that the patient experienced irritation and a rash after 2 days of treating with the 63b electrodes.The patient further advised that she did not conduct the time test when changing to the 63b electrodes.The customer service representative advised to conduct the time test and report back to customer service if there are any issues.The patient stated the 63b electrodes also caused a rash.The patient saw the doctor and was prescribed a cream for the irritation.The doctor told her to call zimvie.The patient stated she told the doctor she was going to let her skin heal and try again.The patient stated she wore 63b electrodes for one hour the first day and two hours the next day.The patient stated her skin immediately was irritated.The patient was advised by a zimvie customer service representative to stop wearing the electrodes until her skin completely healed.The 63b electrodes were not returned for evaluation.
Additional Manufacturer Narrative
Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies between fda medwatch form 3500a and gudid.Corrections: d1: brand name, d2a: device common name, d4: model number, d4: expiration date, g4: pma/510(k)#, h4: device manufacture date, h5: labeled for single use.Additional information: b4: date of this report, g3: date received by manufacturer.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODES, 63B, SPINALPAK/ORTHOPAK
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 18015733
• Report Number: 0002242816-2023-00114
• Device Sequence Number: 15099468
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/10/2024

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: 11/30/2024
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 300801
• 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; Not provided
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 05/30/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic