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

Model Number MID-C 125

Device Problem Break (1069)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

On 07-dec-2023 apifix was notified that patient (b)(6) has a broken apifix screw.

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.

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.

• Brand Name: MID-C 125
• 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.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18442025
• MDR Text Key: 332620423
• Report Number: 3013461531-2023-00063
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2024
• Date Device Manufactured: 12/26/2021
• 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: 18 YR
• Patient Sex: Male