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

Model Number MID-C 125

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: 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.Surgeon, information analysis: on 24-jan-2024 apifix was notified that patient #(b)(6) , index procedure (b)(6) 2018, had the implant removed on (b)(6) 2023 due to a loose "cap" in the area of the ratchet mechanism.Apifx followed up with the reporter directly for additional information.Despite the attempts, no additional information had been provided.  on 20-feb-2024 additional information was received.According to the surgeon, "patient #249 (albsn), 'ratchet cover loosening' - i already have the implant to send you.Indeed, the cover of the ratchet mechanism came loose (in fact, it was lost during the sterilization process).I will ask for an xray during march to assess the maintenance of the correction and flexibility of the curve.Locally, i don't think there was a spontaneous fusion." risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.The risk of cover disconnection from base has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.The device is expected to be returned where a failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.

Event Description

On 24-jan-2024 apifix was notified that patient #(b)(6), index procedure (b)(6) 2018, had the implant removed on (b)(6) 2024 due to a loose "cap" in the area of the ratchet mechanism.

• 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: 18746495
• MDR Text Key: 335848738
• Report Number: 3013461531-2024-00007
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-040
• Device Lot Number: AF-11-04-17
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2017
• 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 Age: 19 YR
• Patient Sex: Female