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

Model Number	MID-C 125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Physical Asymmetry (4573)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional 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 performed on (b)(6) 2021 on (b)(6) 2023, apifix was notified that patient (b)(6) has developed significant proximal junctional kyphosis, pjk, ( t8-t10, treated with extender lenke 5) and that the surgeon will most probably remove the device in 6 months (~ 3y post op).The correction of the curve in the ap is good per the doctor's measurements.On (b)(6) 2024 apifix was notified that patient (b)(6) would be having their apifix device removed at the end of the month.The surgeon wanted to monitor the device for another six months. it has now been six months since that follow up and the surgeon has decided to remove the device.On (b)(6) 2024 apifix was notified that patient #491 implant was removed on (b)(6) 2024 as planned.It was further reported that the device was undamaged, and the reason for removal was "pain after significant weight gain & increased kite angle."  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.The risk of curve progression is a known risk. the event of spine imbalance is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally section.Spine imbalance post-surgery can result from curve progression, improper device use, or treating not within the indications for use.Imbalance can also be an aggravation of a pre-op condition.The risks have been characterized and documented as acceptable within full risk assessment.The explanted device is expected to be returned to the manufacturer and will be evaluated; upon its completion, once new information comes to light, then a supplemental medwatch report will be submitted.
Event or Problem Description
On (b)(6)2023, apifix was notified that patient (b)(6) has developed significant proximal junctional kyphosis, pjk, ( t8-t10, treated with extender lenke 5) and that the surgeon will most probably remove the device in 6 months (~ 3y post op).The correction of the curve in the ap is good per the doctor's measurements.On (b)(6) 2024 apifix was notified that patient (b)(6) would be having their apifix device removed at the end of the month.The surgeon wanted to monitor the device for another six months. it has now been six months since that follow up and the surgeon has decided to remove the device.Device removed on (b)(6) 2024; no report of patient harm/complications was received.
Additional Manufacturer Narrative
Device was returned to manufacturer for analysis.Engineering analysis: during inspection the device appeared normal with no obvious signs of failure.The extender was removed, and the spherical rings were inspected for wear, no wear was found.Since the reason for removal was not related to the device, the retrieval and analysis protocol was not conducted.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.This risk has been assessed and found to be acceptable.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.The risk of curve progression is a known risk.The event of spine imbalance is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally section.Spine imbalance post-surgery can result from curve progression, improper device use, or treating not within the indications for use.Imbalance can also be an aggravation of a pre-op condition.The risks have been characterized and documented as acceptable within full risk assessment.

• Brand Name: MID-C 125
• Common Device Name: 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.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18701591
• Report Number: 3013461531-2024-00006
• Device Sequence Number: 6290435
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-02-004-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Sex: Female