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

Model Number	1067724-2
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Burn(s) (1757); Pain (1994)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the 20" lead wire had exposed wires and burned her skin.The patient's skin was res.The pain was rated about an 8 out of 10 for a few days.The patient did not take pain medication and did not seek medical attention.She did use first aide cream on the burn.No additional information has been provided at this time.
Additional Manufacturer Narrative
A visual inspection of the customer returned product was performed.Included was a 20" lead wire part no.1067724-2, rev f, received in shipping mailer cushion envelope appearing to be in bad physical condition.One cable assembly was tested for electrical resistance/continuity.The 20" cable assembly failed the test.Therefore, it is confirmed that the connecting cable failed electrical resistance/continuity test/ verification.All test inspections were completed using mtr-12890270 with calibration due on (b)(6) 2025, along with tf1047 s/n (b)(6), which does not require calibrations.Test/ inspections were completed by the quality department on (b)(6) 2024.This complaint is based upon well-known failure mode, and thus a summary investigation is being completed per sop 114.0.3.At a minimum, the dhr will be reviewed, and electrical resistance/ continuity tests will be conducted.This summary investigation is limited to the following specification drawing/ part numbers: 1067724- () rev f.During the investigation, the failure mode identified after examination of the patient lead wire is jacket material deteriorating.The most likely root cause for this failure mode is a material failure.Review of the information provided by the customer and along with 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 contacted as part of the capa investigation, and the product was not pulled from stock for evaluation.Capa-000004-2023 was initiated to investigate the broken patient cable lead wires, and hhed-2024-00002 was initiated to evaluate and assess patient risk.Therefore, no further actions are required at this time.This is a well-established failure mode, which does not directly or indirectly cause harm or injury to the patient, but only results in a temporary suspension of treatment.The failure was not confirmed for the reported condition of "exposed wire burned skin".Review of complaint history identified (b)(4) total complaints from ((b)(6) 2023) to ((b)(6) 2024) for pn (1067724-2) and events related to (burn).Keyword search criteria: (complaint code: medical: burn) the search could not be specified further because the main complaint was burn.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "burn".Therefore, no further actions are required at this time.(b)(6) medical will continue to monitor for trends.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.
Event or Problem Description
It was reported that the 20" lead wire had exposed wires and burned her skin.The patient's skin was red.The pain was rated about an 8 out of 10 for a few days.The patient did not take pain medication and did not seek medical attention.She did use first aide cream on the burn.No additional information has been provided at this time.
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, h6: evaluation codes.Additional information: b4: date of this report, g3: date received by manufacturer.Second/final attempt was made by phone.The exposed wire on the 20" lead wire burned the patient's skin.The pain was about an 8 out of 10 for a few days.The patient did not take pain medication and did not seek medical attention.This is considered a serious injury and this complaint is considered reportable.The failure was not confirmed for the reported condition of "exposed wire burned skin".Review of complaint history identified (0) total complaints from (march 14, 2023) to (march 14, 2024) for pn (1067724-2) and events related to (burn).Keyword search criteria: (complaint code: medical: burn) the search could not be specified further because the main complaint was burn.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "burn".Therefore, no further actions are required at this time.
Event or Problem Description
It was reported that the 20" lead wire had exposed wires and burned her skin.The patient's skin was red.The pain was rated about an 8 out of 10 for a few days.The patient did not take pain medication and did not seek medical attention.She did use first aide cream on the burn.No additional information has been provided at this time.

• 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: 19102055
• Report Number: 0002242816-2024-00045
• Device Sequence Number: 7427991
• Product Code: LOF
• UDI-Device Identifier: 00812301020300
• UDI-Public: 00812301020300
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/24/2026

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: Lay User/Patient
• Device Model Number: 1067724-2
• Device Catalogue Number: 1067724-2
• Device Lot Number: 2218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 08/22/2024; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic