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

Model Number MID-C 125

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: 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 and was found to be able to hold 700n load for 10 million cycles of axial load.Misuse : the x-ray demonstrates that the extender is extended significantly below the screws (which is not in line with apifix surgical technique) causing a high moment that may lead to an increase in the kyphosis, blocking of the polyaxiality, and end up with breakage.The present case was performed using the mis approach, the use of the mis technique is not recommended by the company and the surgical technique instructs is to perform the surgery with an open midline incision material and manufacturing: the production process and material data were reviewed and found acceptance and compliance with the product specification.Conclusion: misuse: wrong location of the extender ring and the upper screws.The present case was performed using the mis approach, the use of the mis technique is not recommended by the company and the surgical technique instructs is to perform the surgery with an open midline incision 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.Additional surgeons training on the implantation procedure is required.Risk assessment: at the time of this report (feb 2021), the company's incident rate due for implant breakage is 3.43%.And post mitigations addressing implant breakage, 2.35%.Which is well within the rate reported in the literature (0-8.3% %) ( cer dms-727 rev t).The risk of the broken rod has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.7).

Event Description

On (b)(6), 2021, the surgeon reported that follow 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: 11378366
• MDR Text Key: 241431012
• Report Number: 3013461531-2021-00008
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/21/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-04-17
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 11/21/2017
• 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