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	11/25/2024
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 (b)(6) 2024 apifix was notified that patient # (b)(6) had his implant removed on (b)(6)2024.According to the report received, 'planned removal because of skeletal maturity.No patient complaints, no infection, very little metalosis.Removed implant was intact and retained by the patient.' 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.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
On (b)(6) 2024 apifix was notified that patient # (b)(6) had his implant removed on (b)(6)2024.According to the report received, 'planned removal because of skeletal maturity.No patient complaints, no infection, very little metalosis.Removed implant was intact and retained by the patient.'.

• 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: 21033957
• Report Number: 3013461531-2024-00062
• Device Sequence Number: 9156202
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

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: 04/19/2026
• Device Model Number: MID-C 115
• Device Catalogue Number: AFS-115-040
• Device Lot Number: AF-11-046-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• 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: 19 YR
• Patient Sex: Male