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

Model Number MID-C 105

Device Problem Break (1069)

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

Event Date 06/28/2023

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.Surgeon, x-ray, information analysis: patient #(b)(6) index procedure was performed on (b)(6) 2020.On 19-dec-2023 apifix was notified that patient #(b)(6) underwent removal surgery on (b)(6)2023.According to the reporter, at the end of (b)(6) 2023 an x-ray showed the apifix screw at t12 was fractured.The patient wanted to finish their soccer season before addressing the fractured screw.On (b)(6) 2023, the surgeon removed the apifix device from the patient.Risk assessment: screw breakage, in general, can result from inserting the screws in a wrong trajectory that locks the poly-axiality, improper screw size selection, applying improper side forces on the counter-torque feature of the screw when torquing, or insertion of the screw partially into the pedicle.Screw breakage may be reported together with pain and neurologic complication of weakness.Screw fracture/breakage is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally section.The risk of screw breakage has been quantified, characterized, and documented as acceptable within full risk assessment.The explanted device is expected to be returned to the manufacturer and will be evaluated.Following the evaluation, if new pertinent information comes to light, then a supplemental medwatch report will be submitted.

Event Description

On 19-dec-2023 apifix was notified that patient #(b)(6) underwent removal surgery on (b)(6) 2023.According to the reporter, at the end of (b)(6) an x-ray showed the apifix screw at t12 was fractured.The patient wanted to finish their soccer season before addressing the fractured screw.On (b)(6) 2023, the surgeon removed the apifix device from the patient.According to the surgeon, the patient's curve was stable enough that another apifix device was not needed.

Manufacturer Narrative

Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.The lp screw was fractured close to the mid-point of the screw.The screw fracture location was likely intrapedicular.Beach marks were visible on the fracture surface indication fatique failure.Fracture initiation appears to be the leading radius of the thread form.A retrieval wear analysis was not conducted as the failure mode was obvious, screw fracture, but some wear was visibly observed on the spherical ring of the body.This wear did not appear to breach all layers of the adlc coating.No wear was visibly observed on the spherical ring of the pole.

• Brand Name: MID-C 105
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18510430
• MDR Text Key: 333537913
• Report Number: 3013461531-2023-00065
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128022
• UDI-Public: 07290018128022
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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-02-003-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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: 17 YR
• Patient Sex: Female