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

Model Number	MID-C 125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 18-jul-2024, apifix was notified that patient # (b)(6) (pas# 090-a011) presented with back pain and a broken rod at the clinic.The patient, who is approximately 2.5 years post-index surgery for lenke 1, is scheduled to undergo a procedure on (b)(6) 2024, to remove the implants.The broken rod will not be replaced during this procedure.
Additional Manufacturer Narrative
Investigation: 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.Surgeon, information analysis: patient # (b)(6) (pas# 090-a011) index procedure was performed on (b)(6) 2022 on 18-jul-2024, apifix was notified that patient # (b)(6) (pas# 090-a011) presented with back pain and a broken rod at the clinic.The patient, who is approximately 2.5 years post-index surgery for lenke 1, is scheduled to undergo a procedure on (b)(6) 2024, to remove the implants.The broken rod will not be replaced during this procedure.On (b)(6) 2024 patient underwent removal surgery.No report of patient harm/complications was received.Reoperation events are a known risk that was assessed and recorded by the product risk assessment.Implant breakage is addressed in the ifu (dms-4472 rev g, dms-766 rev u) as potential risks associated with the mid-c system and spinal surgery generally.The risk of broken rod - implant breakage has been assessed and found to be acceptable (dms#777 rev s hazard id 106- mechanical failure resulting in breakage of rod) the risk has been quantified, characterized, and documented as acceptable within full risk assessment.The explanted device has been returned to the manufacturer for analysis.Upon completion of the evaluations, once additional relevant details become available; a supplemental report will be submitted.
Additional Manufacturer Narrative
Return analysis the explanted device was returned, and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was obviously fractured in the pole component around the mid-point of the pole.Post-fracture, the device remained implanted as the fracture plane, inside of the body, and edge of the base and pole showed signs of wear.The fracture plane was worn smooth and thus fracture mode is unable to be identified.The spherical rings were inspected for wear.No wear was visibly observed on the spherical ring of the pole.Over the years, the company already implemented corrective action with the following: - on nov 2017, all surgeons received a letter detailing the importance of screw insertion trajectory.The topic is also covered in the company's training presentation.- eco-38 (approved in h170001/s002): replaced the mid-c 125 that extends by 40 mm to mid-c 125 that extends by 50mm allowing more overlap between the pole and base.- eco-46 (approved in h170001/s002): a trial tool added to the surgical tools to aid the surgeon in detecting if access tissue remains below the implant.- on march 2020, the topic of practicing severe sports added to the mid-c training presentation.A precaution about severe sports was included in the ifu approved in h170001.- on october 2020, as part of apifix commitment to continuous improvement, capa #020-01 was initiated to further investigate to prevent and minimize the rate of implant breakage.- eco-13264 (approved in h170001/s015): increase strength through: decrease stress concentrations and increase cross sectional area at critical regions.

• Brand Name: MID-C 125
• Common Device Name: 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 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: 19960450
• Report Number: 3013461531-2024-00033
• Device Sequence Number: 12546818
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2020
• 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
• Patient Age: 15 YR
• Patient Sex: Female