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 Problems Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Patient #493 index surgery was perfomed on (b)(6) 2021.On (b)(6) 2022, the surgeon contacted apifix and notified that the patient is having issues with worsening hunchback (kyphosis) and implant prominence.The surgeon was seeking advice on how to proceed with the patient.

Manufacturer Narrative

Patient #493 index surgery was perfomed on (b)(6) 2021 on (b)(6) 2022, the surgeon contacted apifix and notified that the patient is having issues with worsening hunchback (kyphosis) and implant prominence.The surgeon was seeking advice on how to proceed with the patient.On (b)(6) 2022, after review of patient #493's information, apifix provided a suggested path forward.  patient #493: the coronal plane lappears to be worsening scoliosis and increasing kite angle.  it looks like over time on the sagittal plane, the proximal device extender angle is increasing, and the sagittal vertical axis is becoming more negative as the lumbar lordosis increases.  the main concern is that the angle between the distal apifix screw and the device is <75 degrees now.  that may result in lack of movement of the polyaxial joint which may lead to device breakage.' apifix does not believe that it would be feasible to extend the liv down 1 level because the distal junctional kyphosis is more severe.Apifix provided a few options: leave it knowing that the patient will likely have progressive prominence / pain and likely device failure.Revise the apifix by moving lower instrumented vertebra 1 level higher (to t11).Both apifix smes would have chosen t11 as the initial div.Revise to fusion.Apifix communicated back to the surgeon that option #3 may be the preferred option for this case.As of the date of this report, apifix was not informed what course of action was taken with the patient.Once information is provided a follow-up mdr report will be submitted.Reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev q; this complaint does not change the occurrences rate.The risk of screw prominence has been assessed and found to be acceptable.The current rate for screw prominence for lp screws 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.Per the picture received from the surgeon, the patient's low bmi in combination with the location of the lower screw at t12 may have contributed to the prominence of the screw although it was an lp screw.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 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: 15091829
• MDR Text Key: 302074395
• Report Number: 3013461531-2022-00029
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: 170001
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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-07-036-20
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Date Device Manufactured: 08/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female