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 Codes	Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.On 03-nov-2024 apifix was notified that patient # (b)(6); (pas #117-a029) is scheduled for a rod exchange revision surgery on (b)(6) 2024.On 04-nov-2024 additional information was received.According to the reporter, the reason {for the re-op} is that the rod the patient has now reached full extension/ distraction, and their curve is progressing again.They're going to replace the rod with a longer one.On (b)(6) 2024 additional information was received.This patient was 9 years old when they were diagnosed with scoliosis, this making this patient an eos patient.Patient was treated outside indication of 'adolescent idiopathic scoliosis (ais) having a single curve and classified as lenke 1 (thoracic major curve) or lenke 5 (thoracolumbar/lumbar major curve).Explanted device is expected to be returned to manufacturer, and an evaluation will be conducted.When additional information is received a follow up mdr will be submitted.
Event or Problem Description
On 03-nov-2024 apifix was notified that patient # (b)(6); (pas #117-a029) is scheduled for a rod exchange revision surgery on (b)(6) 2024.On 04-nov-2024 additional information was received.According to the reporter, the reason {for the re-op} is that the rod the patient has now reached full extension/ distraction, and their curve is progressing again.They're going to replace the rod with a longer one.
Additional Manufacturer Narrative
Engineer analysis: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.There were no obvious manufacturing or design defects which contributed to the removal.This is supported by the notes that the patient outgrew the rod.The distal spherical ring showed no visible signs of wear.The wear analysis portion of retrieval and analysis protocol (dms-5587) was not conducted because the reason for removal was due to patient outgrowing the length of the device.Implant at maximum elongation: patient was treated outside indication of 'adolescent idiopathic scoliosis (ais) having a single curve and classified as lenke 1 (thoracic major curve) or lenke 5 (thoracolumbar/lumbar major curve)'.

• 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: 20732765
• Report Number: 3013461531-2024-00057
• Device Sequence Number: 8499186
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• 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: 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): 07/29/2025

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 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-09-091-21
• 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: 11/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 YR
• Patient Sex: Female