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

Model Number MID-C 125

Device Problem Break (1069)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 08/24/2023

Event Type  malfunction  

Event Description

Patient #(b)(6) (pas #086-0a046) index procedure was performed on (b)(6) 2022.During monitoring, as part of the pas study, apifix was made aware on (b)(6) 2023 that patient #(b)(6) (pas #086-a046) had distal screw breakage and pain.The patient was given a corset brace and will be followed up in 1 month.

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) (pas #086-0a046) index procedure was performed on (b)(6) 2022 during monitoring, as part of the pas study, apifix was made aware on (b)(6) 2023 that patient #(b)(6) (pas #086-a046) had distal screw breakage and pain.The patient was given a corset brace and will be followed up in 1 month.Risk assessment: screw breakage 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 took 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

Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.Localized material deformation was observed on the polyaxial housing of the spherical ring which contained the fractured screw.This likely occurred during polyaxial joint travel and the screw or nut impacted the housing causing the material to deform.Due to this localized deformation, the travel of the spherical ring was reduced.This reduced travel may have contributed to failure of the screw by limiting motion and inducing more bending moment a on the screw than otherwise would be experienced.Because the early x-rays show normal angulation, i don't think it happened at surgery but instead on an extreme (or multiple) forward flexion bend.The hex on the screw likely impacted and deformed the material and the screw angle couldn't return to normal, leading to a screw fracture.

• 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.; 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: 17763375
• MDR Text Key: 323578514
• Report Number: 3013461531-2023-00042
• 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: 03/26/2024

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 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
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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: 17 YR
• Patient Sex: Female