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

Model Number MID-C 125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

Patient #(b)(6) index procedure was performed om (b)(6) 2019.On (b)(6) 2022 apifix was notified that the patient is experiencing 'sharp pains with radiation'.

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.Patient #(b)(6) index procedure was performed om (b)(6) 2019.On (b)(6) 2022 an apifix representative was notified by a patient's father that the patient is 'suddenly experiencing 'sharp pains with radiation'.Apifix followed up with the patient's surgeon requesting additional information, specific to the patient's status.On (b)(6) 2022, the surgeon notified apifix that the issue might be a 'ratchet problem', further noting that "it is very difficult to communicate with the patient and agree on the most logical line of action." apifix has requested recent patient x-rays.No additional information had been provided to date.The risk of pain is a known risk.Pain associated with scoliosis is well described in the literature regardless of having corrective surgery.Pain can also be a transient complaint associated with the surgical procedure or be secondary to device failure, infection/inflammation, curve progression, screw pull-out, loosening, migration, protrusion, and prominence.The event of pain is addressed in the ifu as a warning and as potential risks associated with the mid-c system and spinal surgery generally.This risk of pain has been assessed and found to be acceptable.The reported event may lead to a revision/removal surgery; apifix believes that subjecting a patient to another round of anesthesia and additional surgery carries inherent risks, and in an abundance of caution, apifix is reporting this event.Should additional information be made available, apifix will file a follow up mdr.

Manufacturer Narrative

On 29-nov-2022, apifix was notified that the patient is scheduled for removal surgery on (b)(6) 2022.Apifix followed up with the distributor (30-nov) to provide updates, if possible, regarding the reason for removal & to provide images from the case and returned product for evaluation.  on (b)(6) 2022, the (index) surgeon notified apifix that a second surgeon would be removing the device, adding that the second surgeon has flex extension x-rays which demonstrate ratchet malfunction.On (b)(6) 2022, the implant was removed from the patient with no further instrumentation; no report of patient harm or complications was received.The device was returned to apifix for further evaluation.Upon completion of that evaluation, the complaint record will be updated and a follow-up mdr will be submitted.

Manufacturer Narrative

Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.The spherical ring of the base was missing upon arrival.It was difficult to turn the control pin and it felt gritty while turning.Once in idle mode the device was able to be shortened as designed.The device was put into ratchet mode and extended.Any movement of the control pin or pole was very challenging.When lengthened and more of the pole shown, tissue remnants were shown.The exact cause of this malfunction could not be investigated because the internal mechanism is sealed by permanent closure (weld), but it is suspected that tissue growth within the device could be the cause because every motion related to the internal mechanism was more challenging than usual.There were no obvious manufacturing or design defects which contributed to the failure.The remaining spherical showed light wear, with minor scratching.

• Brand Name: MID-C 125
• Type of Device: 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.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 15876104
• MDR Text Key: 307989368
• Report Number: 3013461531-2022-00064
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-03-01-19
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 11/29/2022
• Supplement Dates FDA Received: 12/18/2022; 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• 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 Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female