MAUDE Adverse Event Report: APIFIX LTD. MID-C 95; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 95

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

On 20-feb-2024 apifix was notified on an upcoming revision case with patient #(b)(6) planned for (b)(6) 2024.On (b)(6) 2024 apifix was notified that patient #(b)(6) underwent revision surgery on that day during which the entire mid-c system was replaced.No report of patient harm/complications was received.  apifix followed up with the reporter regarding the return of the explanted device.According to the reporter "the implant did not fail, it just reached the maximum growth potential.".Since the device's removal did not result from a device failure, the device is not returning.

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.On 20-feb-2024 apifix was notified on an upcoming revision case with patient #(b)(6) planned for (b)(6) 2024, due to implant at maximum elongation.On (b)(6) 2024 apifix was notified that patient #(b)(6) underwent revision surgery on that day during which the entire mid-c system was replaced.No report of patient harm/complications was received.  apifix followed up with the reporter regarding the return of the explanted device.According to the reporter "the implant did not fail, it just reached the maximum growth potential.".Since the device's removal did not result from a device failure, the device is not returning.Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The events of 'implant failure to maintain extension/curve correction' and 'subsequent surgical interventions are addressed in the ifu as potential risks associated with the mid-c system.Apifix is closing this complaint at this time, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If new relevant information is made available, apifix will re-open and update the complaint record and file a follow up medwatch report.*medical device problem code used was: 3191 - appropriate term/code not available.The mid-c system is a ratchet-based self-expandable rod designed to passively increase its length and subsequently maintain its length as the child bends in the corrective direction and also accommodate the natural growth of the spine of young children.In this case the implant (rod) was at its maximum elongation.The appropriate code which isn't available is 'device at maximum elongation'.

• Brand Name: MID-C 95
• 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: 18941782
• MDR Text Key: 339219997
• Report Number: 3013461531-2024-00016
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 95
• Device Catalogue Number: AFS-095-030
• Device Lot Number: AF-01-067-21
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2021
• 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): Other
• Patient Age: 10 YR