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

Model Number MID-C 125

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

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 and was found to be able to hold 700n load for 10 million cycles of axial load.It is thought that the reason for this breakage is side forces acting on the device.Method- the lower screw was inserted in a trajectory causing the lower part of the implant to be located above the spine instead of beside it.Misuse (men/women)- this patient was a lenke 3 case, and therefore out of the indications.Material and manufacturing- the production process and material data were reviewed and found acceptance and compliance with the product specification corrective action: the company already implemented corrective action with the following: trial tool was added to assist the surgeon in verifying that access tissue below the implant is removed.The trial use became standard practice by early 2019.Also, the company is already doing whatever possible not to allow using the device outside the approved indications, by using the ifu, training presentation, and an in-person meeting with surgeons.Risk assessment: with the present report, the company has a total of 3 cases of base breakage -complaint #, (b)(4), and the current complaint.Breakage of the implant was assessed in the product risk assessment dms-777 rev q, hazard id 1.7 and 1.8 this additional complaint does not change the probability thus the risk reminds acceptable at the time of this report (nov 2020), the company's incident rate due to the implant breakage of the base is 0.69%.The overall failure rate for this category as defined in the company clinical evaluation report , implant for any reason is 6.43%, which is well within the rate reported in the literature ( 0.2%-15.5%) ( cer dms-727 rev r).

Event Description

The doctor reported that an x-ray demonstrates implant breakage.

• 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: 10841551
• MDR Text Key: 216320301
• Report Number: 3013461531-2020-00015
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/24/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 03-01-17
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2017
• 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