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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient #(b)(6) index procedure performed on (b)(6) 2020.On 23-jul-2024 apifix was notified that patient #(b)(6) has a broken screw.Patient is reporting some symptoms, so they are getting a ct to assess for fusion between the two proximal levels.On 11-aug-2024 additional information was received.The screw at t11 broke.Patient is experiencing back pain.Patient is scheduled for a video visit on (b)(6) 2024.The screw that broke in this case was an off the shelf polyaxial screw; not manufactured by apifix. apifix has notified the screw manufacturer of the break.
Additional Manufacturer Narrative
A review of the apifix device history records confirmed that the apifix device was manufactured and tested according to relevant procedures and shipped according to manufacturer's specifications.Apifix is not the manufacturer of the screw which broke in this case; apifix has notified the manufacturer of the screw of this incident and the screw breakage.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.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 screw breakage has been quantified, characterized, and documented as acceptable within full risk assessment.Although there was no information which suggests that the apifix system failed to meet its performance specifications or otherwise perform as intended; apifix cannot rule out that it wasn't contributory to the event, and in an abundance of caution apifix is reporting this event.Should additional relevant details become available; the complaint file and medwatch report will be updated accordingly.

• 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.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 19960435
• Report Number: 3013461531-2024-00036
• Device Sequence Number: 17912407
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/12/2024
• 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: 23 YR
• Patient Sex: Male