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

Model Number	MID-C 125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 07-dec-2023 apifix was notified that patient (b)(6) has a broken apifix screw.
Additional 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: on 07-dec-2023 apifix was notified that patient #(b)(6) index procedure performed on (b)(6)2022, has a broken apifix screw.According to clinical affairs, "(prior to the index procedure) the patient had a 61-degree curve, the implant bridged 8 verts.After the index, the kite angle was straight, 3 upper screws were used.And the distal screw was locked at immediate post-op]" apifix recommends a maximum of 7 segments, where in this case it bridged 8 vertabrae.The extender kite angle was straight and three (3) upper polyaxial screws were used.Per the surgical technique, the extender angle should be between 5°-15° degrees relative to the rod.In this case it was straight (0° degrees).Per the surgical technique, two polyaxial screws are utilized in the procedure.In this case, three (3) polyaxial screws were used.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.Although no revision surgery has taken place, a similar malfunction would cause/contribute to a revision; in an abundance of caution apifix is reporting this event.When further relevant information is identified, the complaint file will be updated and a supplemental medwatch will be filed.
Additional Manufacturer Narrative
On 05-mar-2024 apifix was notified that patient #677 (pas# 038-a007 ) is planned to undergo revision on (b)(6) 2024.On (b)(6) 2024 apifx was notified that patient #677 (pas# 038-a007) underwent revision surgery, during which a new mid-c and extender was used & a new apifix screw was placed at l2.One of the off-the-shelf polyaxial screws was removed (t8).The explanted device is expected to be returned to the manufacturer and will be evaluated.Following the evaluation, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The explanted device was returned to orthopediatrics in warsaw, in, and was subjected to cleaning, steam sterilizing, and sent to apifix israel for engineering evaluation.The reason for removal was obvious, as the apifix screw was broken.The lp screw was fractured close to the mid-point of the screw.The screw fracture location was likely interpedicular.The fracture plane was analyzed via a microscope.It showed indications that the fracture mode was likely fatigue and the fracture initiated at the root radius of the thread.Indications of a likely fast fracture are indicated.Fracture initiation appears to be the leading radius of the thread form.The screw was disassembled, the extender was removed, and the spherical rings were inspected for wear.The spherical ring at the pole side was stuck, it was difficult to rotate.Once freed and cleaned the joint moved more freely but still would get stuck.After rotating the spherical ring again, it was observed that there was deformation at the edge of the spherical ring housing into the space where the spherical ring rotates.This material deformation likely occurred when the screw impinged against the spherical ring housing at the extreme end of polyaxial motion.Therefore, the most likely conclusion is that the polyaxial joint reached the end of travel with significant force, which damaged the housing and caused the polyaxial joint to lock.The locked polyaxial joint then likely caused more force in the screw, leading to its eventual fracture.On the screw nut appear a material deformation to the end thread.It likely occurred when the screw was fractured.The wear analysis portion of the retrieval and analysis protocol was not conducted because the cause of failure was obvious, pedicle screw fracture.No wear was visibly observed on the spherical ring of the body.

• Brand Name: MID-C 125
• Common Device Name: 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.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18442025
• Report Number: 3013461531-2023-00063
• Device Sequence Number: 6883743
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2024

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 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/06/2024; Not provided
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 03/10/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2021
• 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: 18 YR
• Patient Sex: Male