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

Model Number	MID-C 105
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On december 27, 2024, apifix was notified that patient # (b)(6), (pas # (b)(6) underwent a removal surgery on (b)(6) 2024, for reasons that were initially unspecified.Apifix promptly followed up with the reporter to inquire about the rationale for the removal.The reporter clarified that patient # (b)(6) was considered a "graduate" of the apifix device.The surgeon determined that the device was no longer necessary to maintain correction because the patient was skeletally mature and had reached the 3-year postoperative mark.A review of the device history records confirmed that the device was manufactured and tested according to relevant procedures and shipped according to manufacturer's specifications.Although no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix device was received, this event involved a removal surgery.Apifix believes that subjecting a patient to another round of anesthesia and additional surgery carries inherent risks, and in an abundance of caution, apifix is reporting this as an adverse event.Explanted device is expected to be returned to manufacturer where an analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.
Event or Problem Description
On december 27, 2024, apifix was notified that patient # (b)(6); (pas # (b)(6) underwent a removal surgery on (b)(6) 2024, for reasons that were initially unspecified.Apifix promptly followed up with the reporter to inquire about the rationale for the removal.The reporter clarified that patient # (b)(6) was considered a "graduate" of the apifix device.The surgeon determined that the device was no longer necessary to maintain correction because the patient was skeletally mature and had reached the 3-year postoperative mark.
Additional Manufacturer Narrative
The explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.Sem analysis was conducted using a hitachi s-3400n scanning electron microscope at purdue university fort wayne.No signs of significant wear were observed.There were no obvious manufacturing or design defects which contributed to the elective removal of the device.

• 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: 21205789
• Report Number: 3013461531-2024-00067
• Device Sequence Number: 3810268
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: (01)07290018128022
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• 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 Expiration Date: 03/10/2025
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-02-003-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Male