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

Model Number MID-C 125

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/22/2023

Event Type  malfunction  

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.Patient #632 index procedure was performed on (b)(6) 2022.On (b)(6) 2023, apifix was notified that patient #(b)(6) underwent revision surgery on that day due to implant at full extension and the patient was still growing.Apifix followed up with the reporter for additional information which was received.During the patient's revision the surgeon simply moved the proximal poly screws down one level and did not exchange the 125mm mid-c.No report of patient harm/complications was received.Per the reporter, "this was a lenke 1 patient.The implant was at full extension.The surgeon exchanged the polyaxial screws and moved the levels down one level to allow for additional patient growth.No x-rays are available, and the kite angle was fine.This was a preventive revision".Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism resulting in patient re-operation due to inadequate curve correction is a known risk, and has been characterized and documented as acceptable within full risk assessment. the events of 'implant failure to maintain extension/curve correction' and 'subsequent surgical interventions are addressed in the ifu ((b)(4) ) 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 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'.

Event Description

On(b)(6) -2023, apifix was notified that patient #(b)(6) underwent revision surgery on that day due to 'implant at full extension and the patient was still growing'.

• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 17763374
• MDR Text Key: 323577061
• Report Number: 3013461531-2023-00041
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2023

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 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2021
• 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: 16 YR
• Patient Sex: Female