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	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 16-jul-2024 apifix was made aware that patient # (b)(6) (pas# 090-a017) was scheduled for rod exchange on 17-jul-2024 due to broken rod (lenke 5).On (b)(6) 2024, it was reported that the surgery is being postponed.
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 # (b)(6) (pas# 090-a017) inde procedure performed on (b)(6) 2022 on 16-jul-2024 apifix was made aware that patient # (b)(6) (pas# 090-a017) was scheduled for rod exchange on 17-jul-2024 due to broken rod (lenke 5).No report of patient harm/complications was received.On 18-jul-2024, it was reported that the surgery is being postponed.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 (dms-4472 rev g, dms-766 rev u) 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 (dms#777 rev s hazard id 106- mechanical failure resulting in breakage of rod) the risk has been quantified, characterized, and documented as acceptable within full risk assessment.Revision surgery is postponed at this time.Once additional relevant details become available; a supplemental report will be submitted.
Additional Manufacturer Narrative
Patient#: (b)(6), (pas#: (b)(6)) index procedure was performed on (b)(6) 2022.On 16-jul-2024 apifix was made aware that patient#: (b)(6) (pas#: (b)(6)) is scheduled for revision surgery on (b)(6) 2024.On 18-jul-2024, it was reported that the patient who was scheduled for rod exchange on (b)(6) from broken rod (lenke 5) is being postponed.(insurance coverage issues).On 03-sep-2024, apifix was notified that patient#: (b)(6) does not yet have a surgery date.On (b)(6) 2024, patient#: (b)(6) underwent revision surgery during which the mid-c rod and extender were replaced.No report of patient harm/complications was received.Explanted device is expected to be returned to manufacturer for analysis.Device received at apifix on 16-dec-2024; being sent to op.On february 17, 2025 engineer review occurred stating "the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was obviously fractured at the mid-point of the pole and at the pole to spherical housing transition.The fractures appeared to be due to fatigue.Some of the surfaces had been smoothed indicating that the device remained in place post-fracture.This is supported by the complaint record, where many months spanned initial report of breakage and the device removal.The wear analysis portion of retrieval and analysis protocol ((b)(4)) was not conducted because the time of implantation was less than 12 months and the cause of failure was obvious fracture.".

• 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: 19926096
• Report Number: 3013461531-2024-00031
• Device Sequence Number: 15547462
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,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?: 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-07-037-20
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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