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 01/24/2024

Event Type  malfunction  

Event Description

On 24-jan-2024 apifix was notified that patient #(b)(6), index procedure (b)(6) 2018, is scheduled to undergo removal surgery on (b)(6) 2024 due to ratchet malfunction.According to the reporter, the ratchet malfunction was detected one year ago, but it was decided to maintain surveillance until now.The surgeon is concerned about the risk of metallosis, therefore despite not having any complaints, it was recommended to remove the device.

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 24-jan-2024 apifix was notified that patient #(b)(6), index procedure (b)(6) 2018, is scheduled to undergo removal surgery on (b)(6) 2024 due to ratchet malfunction.According to the reporter, the ratchet malfunction was detected one year ago, but it was decided to maintain surveillance until now.The surgeon is concerned about the risk of metallosis, therefore despite not having any complaints, it was recommended to remove the device.On 20-feb-2024 additional information was received.According to the surgeonr, "patient #188 (amfp) - on february 10th, implant was removed as planned.There was a malfunction in the ratchet mechanism, which allowed the system to be compressed.There was some metallosis, especially in the area at the connection between the apifix body and the extender.The column seemed fused to me.Within 3 months i will have an x-ray with bendings to assess the maintenance of the correction and whether there is flexibility." 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 mitigations.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 is expected to be returned where a failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.

• 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: 18746494
• MDR Text Key: 335848736
• Report Number: 3013461531-2024-00008
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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-125-040
• Device Lot Number: AF-09-01-17
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2017
• 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: 19 YR
• Patient Sex: Female