MAUDE Adverse Event Report: APIFIX LTD. MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 125

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

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: patient (b)(6) index procedure was performed on (b)(6) 2022.On (b)(6) 2024 apifix was notified that patient (b)(6) reportedly had sudden pain in the thoracic spine and felt recurring 'cracking' in (b)(6) 2023 which last for a few weeks.X-rays show a loss of distraction of the apifix device.Now, one month later, patient has no complaints.Apifix reviewed the provided information and acknowledged ratchet malfunction. according to the xrays, the reverse advancement of the inner bar occurred between on (b)(6) 2023.Therefore, it is likely that it happened in (b)(6) when patient was experiencing 'pain and discomfort'.  one option would be to replace the system and consider locking the ratchet mechanism.Another option is to continue to observe without intervention.There does not appear to be a significant loss of correction between on (b)(6)2023 and on (b)(6)2024.(apifix measured 2 degrees) it's (curve) less than 30 degrees, and the patient is painless.She is currently 17 years old, which means she is fully grown or close to it.  apifix awaits the surgeon's response on how this case is proceeding.Corrective action: ratchet malfunction (resulting in a backup of the distraction) can result from physical trauma, practicing high-demand sports, and tissue growth inside the ratchet mechanism.Ratchet malfunction may be a coincidental finding and may also be reported together with pain/curve progression/noise.The company took several actions to mitigate ratchet malfunction: eco-13, the ratchet flat spring component was changed to a thicker spring (from 0.15 to 0.25mm).Eco-59, addition of a stopper pin to prevent the pole from dislocating from the base and inherit from the design to prevent the collapse of the ratchet.In march 2020, a highlight of the risk associated with practicing high-demand sports was added to the mid-c training presentation.The company continues to monitor the effectiveness of the mitigation's.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.The risk of the ratchet malfunction has been assessed and found to be acceptable.The risks have been quantified, characterized, and documented as acceptable within full risk assessment the device remains implanted in the patient; therefore a failure analysis of the complaint device could not be completed.Apifix awaits the surgeon's response on how this case is proceeding.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

On (b)(6) 2024 apifix was notified that patient (b)(60 reportedly had sudden pain in the thoracic spine and felt recurring 'cracking' in (b)(6) 2023 which last for a few weeks.X-rays show a loss of distraction of the apifix device.Now, one month later, patient has no complaints.

• Brand Name: MID-C 125
• Type of Device: 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: 18668857
• MDR Text Key: 334977215
• Report Number: 3013461531-2024-00004
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

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
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-09-092-21
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female