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 Failure of Implant (1924)

Event Date 12/29/2022

Event Type  malfunction  

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) index procedure was performed on (b)(6) 2021.On 19-dec-2022 apifix clinical trials manager was informed that patient #(b)(6) was scheduled for revision surgery due to dysfunction of the ratchet mechanism and intermittent thoracic pain dull in nature.Clinical affairs review of x-rays from (b)(6) 2022 and (b)(6) 2022 confirmed the ratchet malfunction (ratchet backup).Revision surgery was performed on (b)(6) 2022 during which "initial apifix implant was removed and replaced with a new implant at the same levels as the initial implant.Screws remained, just a new apifix and outrigger replaced.".No report of patient harm/complications was received.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of the ratchet malfunction has been assessed and found to be acceptable.This event does not increase the probability rating.The total rate of ratchet malfunction for any reason is 1.54%.The risk have been quantified, characterized, and documented as acceptable within full risk assessment 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.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 19-dec-2022 apifix clinical trials manager was informed that patient #(b)(6) was scheduled for revision surgery on (b)(6) 2022 due to dysfunction of the ratchet mechanism and intermittent thoracic pain dull in nature.

Manufacturer Narrative

Return analysis: upon receiving the explanted devices at orthopediatrics in (b)(6), the devices were cleaned and sterilized.The devices were photographed and analyzed.An axial compression force was applied and the device could be forced to retract while in ratchet mode.It is unknown if this is due to a failure of an internal mechanism or if soft tissue had grown inside and prevent engagement of the ratchet.The spherical rings did not show signs of significant wear.A scratch of unknown origin was noted on the spherical ring of the body.The cause of failure is clearly related to dysfunction of the ratchet mechanism and therefore the wear analysis of the retrieval protocol was not conducted.

• 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.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16173161
• MDR Text Key: 308835892
• Report Number: 3013461531-2022-00101
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• 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: MUS-125-050
• Device Lot Number: AF-07-036-20
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• 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: 17 YR
• Patient Sex: Male