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

Model Number MID-C 115

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2022

Event Type  malfunction  

Event Description

Patient# (b)(6).Index procedure was performed on (b)(6) 2022.The surgeon was not happy with the resulting kite angle.After consultation with apifix, the surgeon had a conversation with the family and it had been decided to re-operate with a revision surgery being scheduled for (b)(6) 2022 to achieve the proper kite angle (no implants changed).

Manufacturer Narrative

A review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.After further discussion with the surgeon and op sales rep, it was determined that the kite angle measurement tool was used incorrectly during the surgical procedure.Specifically, there was confusion of how to interpret the markings on the tabs with avatar and the "l" and "r" on each of the two tabs, respectively.It was interpreted that the "r" meant a right curve, and since it was a lenke 1 right scoliosis, this is where the arrow of the alignment tool was fixed.(for clarity, the "r" and the avatar indicate that the mid-c system is place on the right side of the patient and not that the pathology (the curve) is to the right.The root cause of this confusion was a lack of understanding the training.The company conducted additional training to clarify this issue with the surgeon and op sales rep on the day after the index procedure which was the day before the revision procedure.The revision result was reported to be excellent.The company's incident rate of extender misalignment is 2.19% · the risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable (b)(4).

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15154656
• MDR Text Key: 305250872
• Report Number: 3013461531-2022-00036
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2022

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: Health Professional
• 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: 07/13/2022
• Initial Date FDA Received: 08/03/2022
• Date Device Manufactured: 05/20/2020
• 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 Sex: Female