MAUDE Adverse Event Report: APIFIX LTD MID-C 105; POSTERIOR RATCHETING ROD SYSTEM,,

Model Number MID-C 105

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 12/26/2021

Event Type  Injury  

Manufacturer Narrative

First investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released.According to specification.User (surgeon and patient) information analysis: on (b)(6) 2021 the patient had a revision surgery to replace the implant.Screw pull-out can be of either the lower or upper screws and can result, among others, from an anatomical problem, insufficient tissue removal under the implant, initial screw misplacement, practicing high demand sports, improper screw size selection or significant kyphosis.The event may be associated with pain and or curve progression.The company took several actions to mitigate screw pull-out: eco 18, an upper extender component was added to the implant, in part to mitigate upper screw pull-out.Eco-46, a trial tool was added to the surgical tools to aid the surgeon in detecting if access tissue remains below the implant.In march 2020, the topic of practicing high demand sports was added to the mid-c training presentation.In the present case it might be that the trial tool was not used correctly and that tissue remaining under the implant pushed against the implant leading to pull-out of the screw.The patient pain is attributed to the screw pull-out and migration demonstrated in the ct.In addition, the x-ray demonstrated ratchet backup, per the company's measurements this by its own is not of clinical significance as the curve progressed from 15° to 17° which is within the measurement error.Also per the company's measurements the kite angle hasn't increased.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 best assumption in similar past cases was that tissue growth into the ratchet mechanism was the reason for the problem.Risk assessment: the current device rate due to screw pull-out is 1.32% and is in line with the rate reported in the literature.For this type of complication as described in the company's clinical evaluation report (0.4%-4.7%) (cer dms-727 rev t).=the risk of the screw pull-out has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.3).Screw pull-out is a known risk that addressed in the ifu warnings and precautions section: metallic implants can loosen, fracture, corrode, migrate, or cause pain and in section potential risks associated with the mid-c system.Implant migration, loosening or dislocation; fracture or breakage of the implant or pedicle screws, including failure to maintain extension/curve correction reoperation events are a known risk that was assessed and recorded by the product risk assessment dms777 rev q this complaint does not change the occurrences rate.The risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.1 and 1.6).This event does not increase the probability rating.

Event Description

The surgeon reported that the patient complained of pain, the x-ray demonstrated increase in kite angle, and ratchet back up.Ct scan demonstrated screw pull-out, and loosening.

Manufacturer Narrative

Return analysis: the explanted device was returned to orthopediatrics and subject to engineering evaluation.There were no obvious defects observed with the device.Minor wear was observed on the spherical rings and was photographed for reference.The device was subjected to compressive and tensile forces by hand and the ratchet mechanism was not able to move.The exact cause of this could not be investigated because the internal mechanism is sealed by permanent closure (weld).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.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 105
• 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: 13401043
• MDR Text Key: 289286184
• Report Number: 3013461531-2022-00001
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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 Expiration Date: 11/20/2022
• Device Model Number: MID-C 105
• Device Catalogue Number: AF
• Device Lot Number: AF 11-01-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2021
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 12/26/2021
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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