MAUDE Adverse Event Report: APIFIX LTD. MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records confirmed that the device was manufactured and tested according to relevant procedures and shipped according to manufacturer's specifications.On 30-dec-2024, apifix was made aware that patient #(b)(6), who had an apifix inserted from t10-l4 in (b)(6) 2021, presented with increasing low back pain, particularly during work-related activities like lifting and mopping.Upon examination, it was discovered that the rod is fractured.The fracture was present at her last consultation in (b)(6) 2024 but was not identified at that time.Patient has been skeletally mature for over three years and also has an intertransverse process fusion from l2-l4, noted since at least (b)(6) 2023.The connection between the rod fracture and her pain is not definitive.There has been some resistance from the family regarding the removal of the implant.The next appointment is scheduled for (b)(6) 2025.There is no plan for reoperation at this time.Once additional relevant details become available; a supplemental report will be submitted.
Event or Problem Description
On 30-dec-2024 apifix was made aware that patient #(b)(6) that had an apifix inserted from t10-l4 in august of 2021 and has been skeletally mature for over 3 years, presented with increasing low back pain, particularly during work-related activities like lifting and mopping.Doctor noticed that the rod is fractured.It was already fractured when he saw her in (b)(6), but he didn't notice it.The connection between the rod fracture and her pain is not definitive.

• Brand Name: MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 21238911
• Report Number: 3013461531-2024-00068
• Device Sequence Number: 20965651
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: (01)07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-114-040
• Device Lot Number: AF-11-046-20
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female