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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/07/2024
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: on 09-sep-2024 apifix was notified that patient#: (b)(6) (pas#: 091-a060) underwent a revision surgery on that day due to a broken rod.According to the reporter, the patient experienced a "pop" sensation while stretching and a sudden onset of pain began in her back on (b)(6) 2024.Patient went to the emergency department around their college and then were sent to dayton children's hospital on (b)(6) 2024.Patient underwent revision surgery to remove and replace the broken implant.On (b)(6) 2024.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.Implant breakage is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally.The risk of broken rod - implant breakage has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.The explanted device has been returned to manufacturer.A failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.
Event or Problem Description
On 09-sep-2024, apifix was notified that patient#: (b)(6) (pas#: 091-a060) underwent a revision surgery on that day due to a broken rod.According to the reporter, the patient experienced a "pop" sensation while stretching and a sudden onset of pain began in her back on (b)(6) 2024.Patient went to the emergency department around their college and then were sent to (b)(6) hospital on (b)(6) 2024.Patient underwent revision surgery to remove and replace the broken implant.On (b)(6) 2024.
Additional Manufacturer Narrative
Correction: brand name [d1] of the device was incorrectly submitted in the initial report; brand name has been corrected in this report to 'minimally invasive deformity correction (mid-c) system'.Additional information / device evaluation: the explanted device was returned, and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was obviously fractured in the base component, around the spherical ring house of the base.The extender was removed and inspected for wear.No wear was found on the extender and the spherical rings.It is suspected that the [patient] kyphosis lead to repeated impact loading on the device which eventually lead to fracture.There were no obvious manufacturing or design defects which contributed to the failure.Over the years, the company already implemented corrective action with the following: on nov 2017, all surgeons received a letter detailing the importance of screw insertion trajectory.The topic is also covered in the company's training presentation.Eco-38 (approved in h170001/s002): replaced the mid-c 125 that extends by 40 mm to mid-c 125 that extends by 50mm allowing more overlap between the pole and base.Eco-46 (approved in h170001/s002): a trial tool added to the surgical tools to aid the surgeon in detecting if access tissue remains below the implant.On march 2020, the topic of practicing severe sports added to the mid-c training presentation.A precaution about severe sports was included in the ifu approved in h170001.On october 2020, as part of apifix commitment to continuous improvement, capa#: 020-01 was initiated to further investigate to prevent and minimize the rate of implant breakage.Eco-13264 (approved in h170001/s015): increase strength through: decrease stress concentrations and increase cross sectional area at critical regions.

• 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: 20394985
• Report Number: 3013461531-2024-00044
• Device Sequence Number: 6566194
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-09-092-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2021
• 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
• Patient Sex: Female