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

Model Number	MID-C 125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures,and shipped according to manufacturer's specifications.Surgeon, information analysis: patient #877 (pas #052-a010) index procedure was performed on (b)(6) 2023.On 18-apr-2024 apifix was notified that patient #877 (pas #052-a010) is complaining of pain over the implant and issues with the changes in the weather.No implant issues noted.Patient/parents are considering removal surgery and will return for follow-up in three month, or sooner if they decide to proceed with surgery.On 15-aug-2024 apifix was notified that pas# 052-a010 (pt.#877) is scheduled for removal procedure on 20-aug-2024.The risk of (discomfort) pain is a known risk.Pain associated with scoliosis is well described in the literature regardless of having corrective surgery.Pain can also be a transient complaint associated with the surgical procedure or be secondary to device failure, infection/inflammation, curve progression, screw pull-out, loosening, migration, protrusion, and prominence.This risk has been assessed and found to be acceptable.The event of pain is addressed in the ifu (dms-4472 rev g) as a warning and as potential risks associated with the mid-c system and spinal surgery generally.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.The implant is expected to be returned to manufacturer following the removal on (b)(6) 2024.A failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2024 apifix was notified that patient #877 (pas #052-a010) is complaining of pain over the implant and issues with the changes in the weather.No implant issues noted.Patient/parents are considering removal surgery and will return for follow-up in three month, or sooner if they decide to proceed with surgery.On 15-aug-2024 apifix was notified that pas# 052-a010 (pt.#877) is scheduled for removal procedure on (b)(6) 2024.
Additional Manufacturer Narrative
On (b)(6) 2024 apifix was notified that patient (b)(6) (pas (b)(6) is complaining of pain over the implant and significant issues with the changes in the weather.No implant issues noted.Patient/parents are considering removl surgery and will return for follow-up in three month, or sooner if they decide to proceed with surgery.On (b)(6) 2024 apifix was notified that pas# (b)(6) (pt.(b)(6) is scheduled for removal procedure on (b)(6) 2024.Despite multiple requests for the device to be returned for analysis, the reporter has been unresponsive.On (b)(6) 2024 additional information was received.According to the reporter, "there were mixups with the pathology department over the last couple of months.However, i did retrieve and ship everything last wednesday." on (b)(6) 2024 - confirmation of tissue samples sent to anpath for analysis.According to the retieval form, implant was removed on (b)(6) 2024.The implant was undamaged.The reason for removal was 'patient too small and had pain over the implants'.Wear debris was identified over the junction of the device and lengthening portion of the device.No wear over the cranial pedicle scres, wear over the posted screws, classified as grade ii metalosis." device received at apifix on (b)(6) 2024; being sent to op for cleaning/sterilization on (b)(6) 2025 engineer evaluation concluded the no obvious nonconformities or defects were found.

• Brand Name: MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 20189057
• Report Number: 3013461531-2024-00040
• Device Sequence Number: 7002718
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Female