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	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 during monitoring of the pas, apifix identified that patient #(b)(6)) visited the clinic on (b)(6) 2024 where reportedly the most distal proximal screw migrated and is now in the rib head'.The plan is do surgical treatment by removing the device and/or doing psf.  family to call office when decision is made on how they want to proceed.
Additional 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) 2021.On (b)(6) 2024 during monitoring of the pas, apifix identified that patient #(b)(6)) visited the clinic on (b)(6) 2024 where reportedly "the most distal proximal screw migrated and is now in the rib head'.The plan is do surgical treatment by removing the device and/or doing psf.  family to call office when decision is made on how they want to proceed." apifix clinical affairs believes that in the patient x-rays from (b)(6) 2023 the upper screw appeared to have pulled out.When apifix asked if there were any remarks (from pas) from the patient's previous follow-up (b)(6) 2023 regarding the position/pull-out of the screw, the site answered 'no the screw at that time seemed to be in the pedicle.It appears to have migrated on the (b)(6) 2024 images.We can also see that the curve thoracolumbar curve has worsened on the (b)(6) 2024 compared to the (b)(6) 2023 films.' risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment; 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 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.The explanted device is expected to be returned to the manufacturer for analysis after the revision surgery.Upon completion of the evaluations, when additional information comes to light, then a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
On (b)(6) 2024 patient underwent apifix removal surgery and posterior spinal fusion t10-l2 with instrumentation and allograft.
Additional Manufacturer Narrative
Correction: brand name [d1] of the device was incorrectly submitted in the initial report; brand name has been corrected in this report to 'minimally invasive deformity correction (mid-c) system'.Additional information / device evaluation the explanted device was returned, and was subjected to cleaning, steam sterilizing, and engineering evaluation.During inspection, the device appeared normal with no obvious signs of failure.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.Reoperation events are a known risk that was assessed and recorded by the product risk assessment.Screw misplacement/migration is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally.The risk of screw breakage has been quantified, characterized, and documented as acceptable within full risk assessment.

• Brand Name: MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM
• Common Device Name: 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: 19737330
• Report Number: 3013461531-2024-00028
• Device Sequence Number: 7720601
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/29/2025

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
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-02-004-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2024
• Supplement Date Received by Manufacturer: 08/06/2024; Not provided
• Initial Report FDA Received Date: 07/14/2024
• Supplement Report FDA Received Date: 08/07/2024; 01/29/2025
• 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: 18 YR
• Patient Sex: Female