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

Model Number MID-C 115

Device Problem Migration (4003)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

On 15-jan-2024 apifix was notified that patient #(b)(6), index procedure performed on (b)(6) 2023, is scheduled for revision surgery on (b)(6) 2024 due to screw migration.

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.On 15-jan-2024 apifix was notified that patient #(b)(6), index procedure performed on (b)(6) 2023, is scheduled for revision surgery on (b)(6) 2024 due to apifix screw migration.On 11-feb-2024 apifix was notified that patient #(b)(6) underwent revision surgery on (b)(6) 2024, during which the surgeon replaced the apifix screw with two screws and an extender to ensure greater fixation.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r; screw misplacement/migration is addressed in the ifu (dms-4472 rev g) as potential risks associated with the mid-c system and spinal surgery generally.Screw misplacement at the index surgery may lead to migration, curve progression, or pull-out over time.Since optimal screw placement, in the middle of the pedicle, is a complex task, especially in the upper part of the spine where the pedicles are very small, this problem is mainly related to the surgeon's skills and the patient's anatomy.In addition, screw migration may also result from an infection.The event may be associated with pain.Apifix is closing this complaint but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

• Brand Name: MID-C 115
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18701434
• MDR Text Key: 335825372
• Report Number: 3013461531-2024-00005
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 115
• Device Catalogue Number: AFS-115-040
• Device Lot Number: AF-11-046-20
• Date Manufacturer Received: 01/15/2024
• Date Device Manufactured: 04/19/2021
• 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 Age: 13 YR
• Patient Sex: Male