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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 20-dec-2024 apifix was notifed that patient #599 underwent implant removal that day.According to the reporter, the patient has reached skeletal maturity and wants to have it removed.There are no complications or concerns with the device.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 20-dec-2024 apifix was notifed that patient #599 underwent implant removal that day.According to the reporter, the patient has reached skeletal maturity and wants to have it removed.There are no complications or concerns with the device.
Additional Manufacturer Narrative
The explanted device was decontaminated at hospital and returned to orthopediatrics in warsaw, in and was subjected engineering evaluation.There was no alleged deficiency or complaint about the device, removal was elective once the patient reached skeletal maturity.Wear analysis was conducted per retrieval and analysis protocol (dms-5587).The spherical rings were evaluated for wear and indicated wear through the adlc coating to expose the base titanium in multiple locations.High magnification photographs from sem imaging are included.Sem analysis conducted using a hitachi s-3400n scanning electron microscope at purdue university fort wayne.Scratches and possible spalling were observed.There was no obvious failure of the device, which is consistent with elective removal.

• 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: 21187699
• Report Number: 3013461531-2024-00065
• Device Sequence Number: 8603214
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: (01)07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,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: 09/09/2025
• 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
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR
• Patient Sex: Female