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

Model Number MID-C 125

Device Problem Fracture (1260)

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

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: user (surgeon and patient) information analysis: the x-ray demonstrates that the system reached its maximal elongation, which is the weakest point of the rod.In this position, the transverse process below the implant may generate a force acting on the system that can cause the rod breakage.The surgery was performed in a minimal invasive approach (mis), which makes it quite challenging to verify that the surface below the implant is sufficiently clean from any soft or hard tissue before placing the implant.For this reason, the use of mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with an open midline incision.Since (b)(6) 2019, after apifix conversation with the surgeon, he agrees to stop using mis procedure.The patient is a competitive swimmer and continued it for two years post-surgery.Material and manufacturing: the production process and material data were reviewed and found acceptance and compliance with the product specification.Design: the design of the mid-c system is aiming to take mainly axial forces, resulting from the load generated by the distraction of the curve and the relevant body weight.The device was tested in an axial direction (see dms#2896 rev a) and was found to be able to hold 700n load for 10 million cycles of axial load.As part of apifix commitment to continuous improvement, capa (b)(4) was initiated to further investigate to prevent and minimize the rate of implant breakage.The company investigation indicated that implant breakage can result from trauma, practicing severe sports, development of hyper-kyphosis, inserting the pedicle screws in a wrong trajectory, not working according to the surgical technique, and most commonly from the implant reaching its end of the way.Breakages were evident in 3 main regions, the implant base, the main rod, and the rod's connection to the poly-axial joint.The most common point of failure was the implant rod in implants reaching their maximal elongation.Conclusion: misuse: insufficient tissue removal below the implant may be the cause of the device breakage - it is challenging to verify that the surface below the implant is sufficiently clear from access tissue when operating in an mis approach.At the location of the fracture pressure from the transverse process or any other hard tissue, below the implant may lead to rod breakage.For this reason, the use of the mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with a vertical midline incision.From early 2019 the company is not recommending the use of 2 extenders, nevertheless, this does not seem to play a part in the subsequent breakage of the device.Corrective action: the company already implemented corrective action with the following: the use of the mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with a vertical midline incision.Eco-38, replaced the mid-c 125 that extends by 40 mm to mid-c 125 that extends by 50mm allowing more overlap between the pole and base.In (b)(6) 2020, the topic of practicing severe sports was added to the mid-c training presentation.Risk assessment: the device breakage current rate is (b)(4) which is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report ((b)(4)).The risk of the broken rod has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.8 and id 1.7).

Event Description

On jun 02, 2021, the surgeon reported by e-mail that follows up x-ray demonstrated the breakage of the implant.

• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12072976
• MDR Text Key: 266038895
• Report Number: 3013461531-2021-00024
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: CM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2021

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 Operator: No Information
• Device Expiration Date: 11/22/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF 125
• Device Lot Number: AF 11-05-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/27/2021
• Date Device Manufactured: 10/22/2017
• 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