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

Model Number	MID-C 125
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, during monitoring as part of the pas study, apifix was made aware that patient #(b)(6) (pas # (b)(6) reportedly has a device with loss of proximal fixation {superior screw loosening}.Patient reportedly has right shoulder pain and pain when sneezing/coughing.Patient scheduled for revision surgery on (b)(6) 2024.
Additional Manufacturer Narrative
A review of the apifix device history record confirmed that the device was manufactured and tested according to relevant procedures and shipped according to manufacturer's specifications.On (b)(6) 2024, during monitoring as part of the pas study, apifix was made aware that patient # (b)(6) (pas (b)(6) reportedly has a device with loss of proximal fixation {superior screw loosening}.Patient reportedly has right shoulder pain and pain when sneezing/coughing.Patient scheduled for revision surgery on (b)(6) 2024.On (b)(6) 2024 patient underwent revision surgery during which the surgeon replaced the two pedicle screws with longer screws.Nothing was changed with the actual apifix construct.No report of patient harm/complications was received.Apifix notified the manufacturer of the poly-screws of this incident.Explanted screws returned directly to screw manufacturer.Reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev s.Screw loosening is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally.Screw loosening can result from infection, improper insertion at the index surgery, osteolysis, or improper screw size selection.

• 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 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: 20394984
• Report Number: 3013461531-2024-00043
• Device Sequence Number: 15094572
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/08/2024

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-03-080-21
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2024
• Initial Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 08/18/2021
• 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
• Patient Age: 16 YR
• Patient Sex: Male