MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 105
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Patient #890 (pas #(b)(6)) index  procedure was perfomed on (b)(6) 2023.On (b)(6) 2024 apifix was notified that patient #890 (pas # (b)(6)) underwent a revision surgery on (b)(6) 2024 to replace a screw that had migrated.According to the report received, "patient (b)(6) underwent a revision surgery to replace a screw that had migrated.The patient had reported some increased pain and clinically was showing an increased translation and rotation of the spine which resulted in a ct scan.The ct scan verified that the screw had migrated outside of the pedicle.The apifix screw was surgically removed and replaced." risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment; this complaint does not change the occurrences rate.At the time of this report, the incident rate for screw misplacement/migration was well within the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (cer).The event of screw misplacement/migration is addressed in the ifu 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.The explanted device (screw) will not be returned for analysis; therefore a failure analysis of the complaint device could not be completed.
Event or Problem Description
On 03-apr-2024 apifix was notified that patient #890 ((b)(6)) underwent a revision surgery on (b)(6) 2024 to replace a screw that had migrated.

• Brand Name: MID-C 105
• Common Device Name: 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: 19219232
• Report Number: 3013461531-2024-00020
• Device Sequence Number: 8105505
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 105
• Device Catalogue Number: MUS-105-040
• Device Lot Number: AF-03-078-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female