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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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 (b)(6) 2024 apifix was notified that at patient (b)(6) (pas #091-a023)'s 3 year follow-up, x-rays showed that the apifix rod was broken.The patient experienced popping of the device but no back pain associated with it.The patient is scheduled to have the device removed 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 is expected to be returned to manufacturer following the removal.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 at patient (b)(6) (pas #091-a023)'s 3 year follow-up, x-rays showed that the apifix rod was broken.The patient experienced popping of the device but no back pain associated with it.The patient is scheduled to have the device removed on (b)(6) 2024.
Additional Manufacturer Narrative
On 12-dec-2024 patient # (b)(6) underwent removal procedure.The tissue at the surgical site and adjacent to the implant at the time of removal was described as being 'pink' and 'tissue healthy'.No metalosis was observed.The explanted device is expected to be returned to manufacturer.A failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.
Additional Manufacturer Narrative
The explanted device was returned to orthopediatrics in (b)(6) and was subjected to cleaning, steam sterilizing, and engineering evaluation.Upon receipt, the device was obviously fractured at the mid-point of the pole.The fracture surfaces showed signs of post-fracture wear, indicating that the device remained implanted after the fracture event had occurred.Minimal wear was observed on spherical ring which did not appear to be entirely through the adlc coating as the lighter colored base material was not observed.The wear analysis portion of retrieval and analysis protocol ((b)(4)) was not conducted because the cause of failure was obvious, fracture of the mid-c component.

• 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: 20876175
• Report Number: 3013461531-2024-00060
• Device Sequence Number: 18096123
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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: 2021
• 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,Followup
• Report Date (Section B): 07/29/2025

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 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/01/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 15 YR
• Patient Sex: Female