MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; 20" LEAD WIRES, REPLACEMENT

Model Number	1067724-2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device was not returned to high ridge 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 trend.
Event or Problem Description
The patient received the lw notification, and reported that when she immediately after starting treatment that she felt the lead wire coating slipped and cracked and caused her discomfort.After getting our notification letter the patient remembered that she has been in pain since june of 2023.The patient stated that she never reported the pain to high ridge or to her doctor.The patient stated that she did not think there marks on her back and feels that the damage was "internal." the patient claimed that she continues to feel discomfort every few days or sometimes once per week.The patient reported that the pain is an 8 out of 10.The patient claims that her treatment was discontinued in march of 2024 because her bones had fused and the doctor was pleased with her progress.The patient was advised to contact her doctor and report the pain.No further consequences has been reported.The 20" lead wire was not returned for evaluation as the unit and lead wire was discarded upon completion of treatment.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d3: manufacturer, d1: brand name, d2a: device common name, d3: manufacturer, d4: model number, g1: contact office, g4: pma number, g6: type of report, h2, h8, h5: labeled for single use.Additional information in d4, g3, h6: investigation type, findings, and conclusions and h10: additional narrative.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 trend.
Event or Problem Description
The patient received the lw notification and reported that when she immediately after starting treatment that she felt the lead wire coating slipped and cracked and caused her discomfort.After getting our notification letter the patient remembered that she has been in pain since on (b)(6) 2023.The patient stated that she never reported the pain to highridge or to her doctor.The patient stated that she did not think there marks on her back and feels that the damage was "internal." the patient claimed that she continues to feel discomfort every few days or sometimes once per week.The patient reported that the pain is an 8 out of 10.The patient claims that her treatment was discontinued on (b)(6) 2024 because her bones had fused and the doctor was pleased with her progress.The patient was advised to contact her doctor and report the pain.No further consequences has been reported.The 20" lead wire was not returned for evaluation as the unit and lead wire was discarded upon completion of treatment.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: 20" LEAD WIRES, REPLACEMENT
• 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: 19669991
• Report Number: 0002242816-2024-00087
• Device Sequence Number: 6965228
• Product Code: LOF
• UDI-Device Identifier: 00812301020300
• UDI-Public: 00812301020300
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/16/2024

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 Model Number: 1067724-2
• Device Catalogue Number: 1067724-2
• Device Lot Number: 2309
• 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: 07/03/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2023
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic