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

Model Number	MID-C 125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 during monitoring of the pas, apifix identified that at a (b)(6) 2024 clinic visit patient # (b)(6) (pas# 117-a021) reportedly has a broken implant.Specifically "the apifix rod is fractured at the ratchet mechanism site".It was further reported that the treatment plan is a re-op.They will have the patient come back in in 6 weeks on (b)(6) 2024 for further x-rays.Those x-rays will determine if it will be a rod exchange or removal.
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: on (b)(6) 2024 during monitoring of the pas, apifix identified that at a (b)(6) 2024 clinic visit patient # (b)(6), (pas# 117-a021) reportedly has a broken implant.Specifically "the apifix rod is fractured at the ratchet mechanism site".It was further reported that the treatment plan is a re-op.They will have the patient come back in in 6 weeks on (b)(6) 2024 for further x-rays.Those x-rays will determine if it will be a rod exchange or removal.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 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.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Additional Manufacturer Narrative
On (b)(6) 2024 (b)(6) underwent revision surgery during which the broken mid-c rod was replaced.No report of patient harm/complications was received.The explanted device is expected to be returned to manufacturer.A failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.
Additional Manufacturer Narrative
On february 17th 2025 apifix concluded their investigation.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 base and towards the distal end of the pole.The pole fracture planes were worn mostly smooth.Based on x-rays, the fracture location of the pole appears similar to the location of where the locking tooth engaged the pole.The fracture planes of the base appeared to be fatigue fracture.Some wear was observed on the locking tooth.Minimal wear was observed on the distal spherical ring.The wear analysis portion of retrieval and analysis protocol (dms-5587) was not conducted because the cause of failure was obvious, fracture of the mid-c 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: 20514897
• Report Number: 3013461531-2024-00052
• Device Sequence Number: 7110969
• 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: 2022
• 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,Followup
• Report Date (Section B): 03/07/2025

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 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-02-004-20
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/09/2024; 03/07/2025
• 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
• Patient Age: 16 YR
• Patient Sex: Female