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

Model Number	MID-C 125
Medical Device Problem Code	Failure to Align (2522)
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
On 08-aug-2024 apifix was notified that patient (b)(6) underwent revision surgery on (b)(6) 2024 due to a kite angle collapse.According to the report, "we added a screw at t7 to go along with t5&t6 and shortened the mid-c.The apifix screw was unchanged.".
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 was performed on (b)(6) 2022.On (b)(6) 2023, patient (b)(6), underwent revision surgery due to loosen screw and implant at max-extension.(ref: mdr 3013461531-2023-00033) on (b)(6) 2024 apifix was notified that patient (b)(6) underwent revision surgery on (b)(6) 2024 due to a "kite angle collapse".According to the report, "{during revision} we added a screw at t7 to go along with t5&t6 and shortened the mid-c.The apifix screw was unchanged." apifix followed up with the reporter requesting patient images and additional information, however no additional information had been received.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of "extender angle increase" has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Extender misalignment typically results from not properly aligning the extender and the main rod, from selecting improper screw size to anchor the extender, or from fault in the off-the-shelf tool used to lock the extender screws.The misalignment can also occur with time, and the event may be associated with curve progression and implant migration.The investigation findings do not lead to a clear conclusion about the cause of the reported event.Apifix is closing this complaint but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Additional Manufacturer Narrative
On (b)(6) 2024 patient #(b)(6) (pas# (b)(6) underwent revision surgery during which the broken mid-c rod was replaced with a new one.No report of patient harm/complications was received.The explanted device is expected to be returned to manufacturer.A failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.

• 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.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 20143706
• Report Number: 3013461531-2024-00038
• Device Sequence Number: 8369145
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: H170001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-01-069-21
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 11/14/2019
• 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: 14 YR
• Patient Sex: Female