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

Model Number MID-C 125

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

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 (men/women): the x-ray showed that the failure was caused due to a big kyphosis angle, which is measured in this case over 60 degrees post device failure, the patient is out of indications.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.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: (b)(4).

Event Description

On (b)(6) 2021, the surgeon reported 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: 11378030
• MDR Text Key: 242714577
• Report Number: 3013461531-2021-00007
• 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: 02/21/2021

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 Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 03-01-19
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Date Device Manufactured: 03/27/2019
• 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