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

Model Number MID-C 115

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

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: although the surgeon reports the patient beeing treaed per the approved indications, company analysis demonstrates the patient lateral bending x-ray was 50¿ and hence out of undication.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.To protect against such force it is necessary to use the trial tool according to the detailed steps as described in the surgical technique guide 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 (b)(4)) 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.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 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 severe sports was added to the mid-c training presentation in the present clinical center the trial is not used as detailed in the surgical technique, hence access tissue below the implant might have been the contributing cause for the breakage.Due to the patient curve stiffness, the company recommended the patient be revised to fusion, however the surgeon and family decided to revise to a new mid-c system.Surgery is scheduled to (b)(6).Risk assessment: the current device breakage rate due to any reason is (b)(4) 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%) ( (b)(4)).The risk of the broken rod has been assessed and found to be acceptable (dms#:(b)(4)).

Event Description

The patient felt sudden pain without any noise, the x-ray demonstrates implant breakage.

• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 12628584
• MDR Text Key: 276411400
• Report Number: 3013461531-2021-00032
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2021

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: 05/07/2024
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF 05-01-19
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/13/2021
• Date Device Manufactured: 05/07/2019
• 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