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 12/14/2022

Event Type  malfunction  

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 on (b)(6) 2021.On 29-dec-2022 apifix was notified that patient#: (b)(6) has been complaining about pain and overall discomfort.From the clinic notes, "patient is having back pain.  she is tearful and this pain is really bothering her.  she reports low back pain and described as an ache.  she rates the pain a 3 out of 10 but it seems to be really bothering her.  nothing seems to improve her pain.Standing or sitting of prolonged periods make pain worse.  she denies any bowel/bladder issues or extremity numbness/tingling/weakness.  family would like the apifix removed." a surgery will be scheduled as soon as the doctor has time open.On 18-jan-2023 apifix was notified that a removal surgery is planned for the beginning of february.A determination of cause of the patient's pain could not be determined with the available information.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 current pain rate is 3.8%.This risk has been assessed and found to be acceptable per the company cer.(dms-727 rev u).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.Apifix was notified that the removal surgery is planned for the beginning of february.Once additional relevant details become available, a supplemental report will be submitted.

Event Description

On 29-dec-2022 apifix was notified that patient#: (b)(6) has been complaining about pain and overall discomfort.From the clinic notes, "patient is having back pain.She is tearful and this pain is really bothering her.She reports low back pain and described as an ache.She rates the pain a 3 out of 10 but it seems to be really bothering her.Nothing seems to improve her pain.Standing or sitting of prolonged periods make pain worse.She denies any bowel/bladder issues or extremity numbness/tingling/weakness.Family would like to apifix removed." a surgery will be scheduled as soon as the doctor has time open.

Manufacturer Narrative

On (b)(6) 2023 apifix was updated that on (b)(6) 2023 the removal surgery was performed.The patient opted out of adjusting the device; patient wanted it removed since she only wants one surgery.

Manufacturer Narrative

Device was returned to manufacturer for analysis.Engineering analysis: the explanted device was returned and was subjected to cleaning and steam sterilizing.The explant was evaluated by engineering and photographed.Wear analysis of spherical rings.Visual inspection of spherical rings showed minimal signs of wear.Some minor scratches and area of adlc separation were observed.The distal spherical ring was forcibly disassembled from the mid-c for sem analysis on hitachi s-3400n scanning electron microscope at purdue university fort wayne on november 1st, 2023.The worst looking area of the spherical ring was investigated.A scratch was examined under higher magnification.The wear observed worst location of the spherical ring was minor and nothing observed indicated that wear, or any other aspect of the device contributed to the device removal.Curve progression can result from several reasons, such as device misplacement, operating on patients out of the approved indication, implant size selection, extender misalignment, screw misplacement /migration, screw pull-out, implant breakage, infection, ratchet malfunction, and in some cases for no apparent reason.The progression can be either or both of the primary or secondary curve and may also be reported together with pain and or spine imbalance.Cause for the secondary curve progression could not be determined.

• 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 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: 16239017
• MDR Text Key: 309148968
• Report Number: 3013461531-2022-00078
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• 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: MUS-125-050
• Device Lot Number: AF-02-004-20
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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: 17 YR
• Patient Sex: Female