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

Model Number MID-C 125

Device Problem Fracture (1260)

Event Date 02/14/2022

Event Type  Injury  

Event Description

The x-ray demonstrates implant breakage.

Manufacturer Narrative

Investigation : production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.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.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.Risk assessment: the current device breakage rate due to any reason is 4.90% 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 (0.2%-15.5%) ( cer dms-727 rev u).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).Corrective action: over the years, the company already implemented corrective action with the following: in nov 2017, all surgeons received a letter detailing the importance of screw insertion trajectory.The topic is also covered in the company's training presentation.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.Eco-46, a trial tool 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 severe sports added to the mid-c training presentation.In october 2020, the company opened capa (b)(4) to further investigate the cause of failure and manage the device breakage risk and is in the process of implementing 3 ecos to mitigate device breakage further.Eco 8493 - a design change in the 115 implants that will increase the pole-base overlap to 8 mm instead of 3.5.Eco 8494 - a design change in the 105 implants that will increase the pole-base overlap to 6 mm instead of 3.5.Eco 8729 - the addition of a dedicated tool that can bend the 5.5 mm rod of the extender to better accommodate significant kyphosis.

• 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: 13768608
• MDR Text Key: 287178065
• Report Number: 3013461531-2022-00009
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Report Date: 03/15/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/29/2023
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-01-18
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Date Device Manufactured: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial