MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 115

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notified that patient #744 (b)(6) felt some clicking in her back a couple of weeks ago and an x-ray shows failure of the device's ratchet mechanism.Family is deciding between an exchange of the device or fusion.

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, information analysis: patient (b)(6) index procedure ws performed on (b)(6) 2022.On (b)(6)2023 apifix was notified that patient #(b)(6)) felt some clicking in her back a couple of weeks ago and an x-ray shows failure of the device's ratchet mechanism.Family is deciding between an exchange of the device or 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 (b)(6) 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.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 removed or replaced, and then returned to manufacturer for analysis.When further relevant information is identified with which to determine a cause, a supplemental report will be filed.

Manufacturer Narrative

On 13-jan-2024 apifix was notified that patient #(b)(6) underwent revision surgery on (b)(6) 2024 during which the mid-c rod, extender, and proximal screws were exchanged.On 24-jan-2024 apifix was notified that the implant is being returned to the manufacturer for evaluation.

• Brand Name: MID-C 115
• 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 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: 18390423
• MDR Text Key: 331584701
• Report Number: 3013461531-2023-00059
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2022
• 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