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

Model Number MID-C 125

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

Patient # (b)(6) index procedure was performed on (b)(6) 2018.On (b)(6) 2022 apifix was notified that patient # (b)(6) is scheduled for a revision surgery on (b)(6) 2022 due to alleged ratchet 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, x-ray, information analysis: patient # (b)(6) index procedure was performed on (b)(6) 2018.On (b)(6) 2022 apifix was notified that patient # (b)(6) is scheduled for a revision surgery on (b)(6) 2022 due to alleged ratchet malfunction.On (b)(6) 2022 apifix requested patient x-rays which demonstrate the ratchet malfunction; intermittent noise (no pain) prompted an x-ray at 48 months post-op.Images were provided which show that the ratchet has retracted between 42 months post op to 48 months post op.On (b)(6) 2022 the patient was revised to a new implant.The surgeon maintained the existing polyaxial screws and apifix screw & extender, and only replaced the implant.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 (b)(6) 2020, a highlight of the risk associated with practicing high-demand sports was added to the mid-c training presentation.The present case was (b)(6).The company continues to monitor the effectiveness of the (b)(4) mitigation.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev q this complaint does not change the occurrences rate.The risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.4 and 1.6).This event does not increase the probability rating.The total rate of ratchet malfunction for any reason is 1.22% the risks have been quantified, characterized, and documented as acceptable within full risk assessment.

• 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 st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15507778
• MDR Text Key: 306419109
• Report Number: 3013461531-2022-00048
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2022

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-10-01-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/29/2022
• Date Device Manufactured: 11/06/2017
• 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: 17 YR
• Patient Sex: Female