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

Model Number MID-C 125

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Patient (b)(6) index procedure was performed on (b)(6) 2023.On (b)(6) 2023 apifix was notified that patient (b)(6) has screw migration which was evident by two weeks post-op and is worsening at six weeks post-op visit.  the most distal screw and the inferior proximal screw are ploughing (distal screw tip going proximal, inferior proximal screw tip going more medial).This is allowing the kite angle to worsen and the device to lengthen excessively.She is asymptomatic and clinically there is no implant prominence or notable deformity.Neuro intact.Review of the case by an apifix medical expert suggested that the construct failure was caused by early plowing and possible slight pullout of the t10 screw.  on images, the t10 screw looks perfectly positioned within the pedicle. however, the screw looks at bit small (diameter) relative to the pedicle.A larger diameter screw is often better at t10 or t11 in these lenke 5 constructs. i try to completely fill the pedicle to get cortical purchase, which can require 7.5 mm or 8.5 mm screws." on (b)(6)2023 patient (b)(6) underwent revision surgery during which the inferior polyaxial screw was replaced to a larger screw.The apifix screw was replaced to a larger screw as well.No report of patient harm/complication was received.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment (b)(4) ; this complaint does not change the occurrences rate.At the time of this report, the incident rate for screw misplacement/migration was well within the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (cer).The event of screw misplacement/migration is addressed in the ifu (dms-766 rev u) as potential risks associated with the mid-c system and spinal surgery generally.Screw misplacement at the index surgery may lead to migration, curve progression, or pull-out over time.Since optimal screw placement, in the middle of the pedicle, is a complex task, especially in the upper part of the spine where the pedicles are very small, this problem is mainly related to the surgeon's skills and the patient's anatomy.In addition, screw migration may also result from an infection.The event may be associated with pain apifix is closing this complaint but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

Event Description

On (b)(6) 2023 apifix was notified that patient (b)(6) has screw migration which was evident by two weeks post-op and is worsening at six weeks post-op visit.  the most distal screw and the inferior proximal screw are ploughing (distal screw tip going proximal, inferior proximal screw tip going more medial).This is allowing the kite angle to worsen and the device to lengthen excessively.Patient is asymptomatic and clinically there is no implant prominence or notable deformity.Neuro intact.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18272416
• MDR Text Key: 330127051
• Report Number: 3013461531-2023-00057
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Date Manufacturer Received: 11/07/2023
• Date Device Manufactured: 02/08/2021
• 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: 13 YR
• Patient Sex: Female