MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number	MID-C 115
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 apifix was notified that patient #744 (b)(6) felt some clicking in her back a couple of weeks ago and an x-ray shows failure of the device's ratchet mechanism.Family is deciding between an exchange of the device or fusion.
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) index procedure ws performed on (b)(6) 2022.On (b)(6)2023 apifix was notified that patient #(b)(6)) felt some clicking in her back a couple of weeks ago and an x-ray shows failure of the device's ratchet mechanism.Family is deciding between an exchange of the device or fusion.Corrective action: ratchet malfunction (resulting in a backup of the distraction) can result from physical trauma, practicing high-demand sports, and tissue growth inside the ratchet mechanism.Ratchet malfunction may be a coincidental finding and may also be reported together with pain/curve progression/noise.The company took several actions to mitigate ratchet malfunction: eco-13, the ratchet flat spring component was changed to a thicker spring (from 0.15 to 0.25mm).Eco-59, addition of a stopper pin to prevent the pole from dislocating from the base and inherit from the design to prevent the collapse of the ratchet.In (b)(6) 2020, a highlight of the risk associated with practicing high-demand sports was added to the mid-c training presentation.The company continues to monitor the effectiveness of the mitigations.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.The risk of the ratchet malfunction has been assessed and found to be acceptable.The risks have been quantified, characterized, and documented as acceptable within full risk assessment the device is expected to be removed or replaced, and then returned to manufacturer for analysis.When further relevant information is identified with which to determine a cause, a supplemental report will be filed.
Additional Manufacturer Narrative
On 13-jan-2024 apifix was notified that patient #(b)(6) underwent revision surgery on (b)(6) 2024 during which the mid-c rod, extender, and proximal screws were exchanged.On 24-jan-2024 apifix was notified that the implant is being returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Engineering evaluation: the explanted device was returned to manufacturer and was subjected to cleaning, steam sterilizing, and engineering evaluation.On (b)(6) 2024 the cover of the explanted device was removed using a dremel tool and a hammer.Soft tissue was found inside the device.Significant damage of the locking tooth was observed.It is expected that the ratchet malfunction is due to the damage of the locking tooth, as a relatively large section of material is no longer present to support the load.In conclusion, the malfunction in the ratcheting mechanism was primarily due to significant wear and damage to the locking tooth.There were no manufacturing or design defects identified that contributed to this issue.The investigation suggests that the device's failure was a result of material degradation under operational conditions rather than a manufacturing or design flaw.

• Brand Name: MID-C 115
• 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: 18390423
• Report Number: 3013461531-2023-00059
• Device Sequence Number: 2646121
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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,Followup
• Report Date (Section B): 09/26/2024

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 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-11-046-20
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/13/2024; Not provided
• Initial Report FDA Received Date: 12/25/2023
• Supplement Report FDA Received Date: 01/29/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 13 YR
• Patient Sex: Female