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 Code	Physical Asymmetry (4573)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional 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) index procedure was performed on (b)(6) 2021.On (b)(6) 2022 patient (b)(6) underwent revision surgery due to the implant reaching maximum elongation.X-rays revealed that the implant was not placed according to pre-operative plan.Namely, it was placed at t4-t5-t12 as opposed to t5-t6-t12, and over time the implant elongation accommodated curve progression rather than correction.During the revision a new mid-c system which was implanted and located at t4-t5-t11, and per the company's impression the device was still not positioned to fully support the deformity correction.On 12-jun-2024 apifix was notified that patient (b)(6) is being brought back to the or on friday (b)(6) 2024 for apifix removal and transition to posterior spinal fusion.No report of patient harm or complications was received.Apifix followed up with the reporter for additional information, according to the reporter, the patient began to develop a secondary lumbar curvature, thus the reason for the re-op.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of patient re operation due to inadequate curve correction/imbalance is a known risk, and has been characterized and documented as acceptable within full risk assessment.The events of inadequate 'curve correction' and 'imbalance' are addressed in the ifu (dms-766 rev u) as potential risks associated with the mid-c system.The explanted device has been 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 12-jun- 2024 apifix was notified that patient (b)(6) (pas #086-a017) is being brought back to the or on friday (b)(6) 2024 for apifix removal and transition to posterior spinal fusion.No report of patient harm or complications was received.Apifix followed up with the reporter for additional information, according to the reporter, the patient began to develop a secondary lumbar curvature, thus the reason for the re-op.

• 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 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: 19686062
• Report Number: 3013461531-2024-00026
• Device Sequence Number: 3175887
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2024

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-03-080-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/07/2024
• Date Device Manufactured: 12/06/2021
• 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: 16 YR
• Patient Sex: Male