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

Model Number	MID-C 125
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Production process analysis: 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.User (surgeon and patient) information analysis: patient # (b)(6); (pas# (b)(6)) index procedure was performed on (b)(6) 2021.On 06-aug-2024 during monitoring of the pas study, apifix identified that patient # (b)(6);(pas (b)(6)) was at a follow up at clinic on (b)(6) 2024 where it was reported that "the ratcheting system appears to have malfunctioned as it has regressed when compared to previous films and cobb angle has increased to 33 degrees from 22 degrees on previous films.Surgeon discussed moving forward with removal of apifix and doing a posterior spine fusion.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.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.
Event or Problem Description
On 22-jul-2024, during monitoring as part of the pas study, apifix was made aware that patient # (b)(6); (pas # (b)(6)) at the 24-month visit (circa (b)(6) 2023) reportedly has occasional pain and grinding noises from the device with movement.No report of surgical/medical intervention was received.On 06-aug-2024 apifix received additional information regarding patient # (b)(6); (pas (b)(6)).'at a clinic visit on (b)(6) 2024 it was reported that "the ratcheting system appears to have malfunctioned as it has regressed when compared to previous films and cobb angle has increased to 33 degrees from 22 degrees on previous films".Surgeon discussed moving forward with removal of apifix and doing a posterior spine fusion.'.
Additional Manufacturer Narrative
On 27-dec-2024 apifix was notified that patient #(b)(6) underwent device removal on (b)(6) 2024 the explanted device is expected to be returned to manufacturer.A failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.

• Brand Name: MID-C 125
• Common Device Name: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 20123420
• Report Number: 3013461531-2024-00037
• Device Sequence Number: 19620991
• 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
• Report Date (Section B): 12/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-01-069-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/30/2024
• Date Device Manufactured: 09/24/2020
• 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: 17 YR
• Patient Sex: Female