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

Model Number MID-C 125

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

Investigation a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Surgeon x- ray information analysis: the patient was initially operated on (b)(6) 2020.Immediate post-op and 3-month x-rays demonstrate the screw was placed outside of the pedicle and that the device's polyaxialty is locked.(as the correction was good, and the patient had no relevant symptoms (other than the usual post-op pain), the surgeon decided not to change the screw position).In feb 2022, a patient complaint was received of a recurring click, and pain associated with trunk mobilization.Follow up x-rays feb 2022 show that the ratchet mechanism collapsed and also suggested that the apifix lower screw may have pulled out a few millimeters.Placing screws correctly inside the pedicle is the surgeon's expertise and is not related to the apifix system.In addition, the x-rays indicate a ratchet malfunction (resulting in a backup of the distraction).Ratchet malfunction.Corrective action: 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.In the present case, the implant lot is post -eco 13 and 59.Risk assessment reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777.The risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.4 and 1.6).This event does not increase the probability rating.The total rate of ratchet malfunction for any reason posts eco- 59 is 0.7%.The company continues to monitor the effectiveness of the mitigation.At the time of this report (feb 24, 2022), the company's incident rate of screw misplacement is 3.1 % which is well within the rate reported in the literature cer 727 rev u).The risk of misuse-the surgeon does not follow the ifu and/or the surgical technique guide that may lead to pain has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.5) the current complaint does change the risk probability score.Event of pain addressed in the ifu warnings and precautions section: "metallic implants can loosen, fracture, corrode, migrate, or cause pain".

Event Description

The surgeon informed the company that revision surgery is planned for (b)(6) 2022 due to a suspected ratchet malfunction.The patient felt a click, which became recurrent, associated with pain on trunk mobilization.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was evaluated.The device was photographed.During the inspection, the device's ratcheting mechanism did not appear to be functioning properly.Specifically, when the control pin was in ratchet position (arrow of control pin aligned with arrow on device body) the device should "click" upon lengthening and allow no shortening.However, upon applying an axial load the device could be forced to shorten.The exact cause of this malfunction could not be investigated because the internal mechanism is sealed by permanent closure (weld).There were no obvious manufacturing or design defects which contributed to the failure apifix is closing this complaint but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.

• Brand Name: MID-C 125
• 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: 13751950
• MDR Text Key: 290522236
• Report Number: 3013461531-2022-00008
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MID-C 125
• Device Catalogue Number: AF 125
• Device Lot Number: AF -10-01-19
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/13/2022
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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 Outcome(s): Required Intervention