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

Model Number MID-C 125

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 apifix was notified by the surgeon that the distal screw is pulling out of one of his patients.The doctor added that it is very likely he will have to review/revise the patient, and as soon as he has some time, he will send the postoperative images.

Manufacturer Narrative

Production process analysis: 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.User (surgeon and patient) information analysis: patient#: (b)(6) underwent index surgery on (b)(6) 2022. the surgery and the immediate postoperative period were uneventful, however, in the x-ray taken after the surgery, the surgeon realized there was a pull-out of the lower screw.As the patient was asymptomatic, and given the holiday and christmas period that was approaching, the surgeon decided to wait a few days to reassess this patient.Following the holidays, the patient presented pain irradiating to the right thigh.Surgeon plan is to revise the patient on (b)(6) 2023, changing the lower screw to l3.The surgeon's assumption was that during pedicle preparation he violated the lateral cortical (pedicle).He did a correction on the trajectory with the pedicle finder.When he put in the screw,  he felt good resistence to progression (above 4 on the screwdriver) and o-arm confirmed a good position but he thinks this was the reason for pedicle fracture and screw dislocation (this is not a true pull-out).On 10-jan-2023 apifix was notified that the patient underwent a revision surgery on (b)(6)2023 in which the l4 pedicle screw was removed and a new pedicle screw (7x40) was placed in the l3 pedicle.Intraoperative verification of the placement of the new screw was performed with o-arm , as well as the confirmation of the absence of any bone fragment in the foramen of l4.The surgeon decided not to change the upper screws to a level above, so the mid-c had to be replaced with a shorter one (initially 125mm, replaced by 105mm). the patient is pain-free and was discharged the day after surgery.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of screw pullout has been assessed and found to be acceptable the current screw pullout rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

• 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: 16181775
• MDR Text Key: 308919769
• Report Number: 3013461531-2022-00074
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-09-092-21
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Date Device Manufactured: 04/25/2022
• 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 Sex: Male