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

Model Number	MID-C 115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06-nov-2024 apifix was notified that patient # (b)(6) heard a "pop", x-rays revealed an implant breakage over the ratchet area.The plan is to explant the device in (b)(6) 2024.
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: on 06-nov-2024 apifix was notified that patient (b)(6) heard a "pop", x-rays revealed an implant breakage over the ratchet area.The plan is to explant the device in (b)(6).Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.Implant breakage is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally.The risk of broken rod - implant breakage has been assessed and found to be acceptable.The risk has been quantified, characterized, and documented as acceptable within full risk assessment.
Additional Manufacturer Narrative
On (b)(6) 2024 patient #746 underwent removal procedure without additional instrumentation."the plan is to watch the patient and proceed to fusion at later time, if necessary." 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.
Additional Manufacturer Narrative
The explanted device was returned to manufacture, accompanied by a decontamination certificate.Upon inspection, the device was photographed and examined thoroughly.The weld seam was analyzed microscopically, revealing no visible inclusions or defects.Despite extensive evaluation, no definitive cause for the detachment of the welded cover could be identified.Minor wear was observed on the locking tooth, though it was deemed unrelated to the failure.Additionally, one spherical ring was inspected, with no wear detected.This failure mode is considered anomalous, as the device did not exhibit any detectable defects or wear patterns that typically correlate with such a failure, suggesting an isolated or highly unusual occurrence.

• 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: 20817060
• Report Number: 3013461531-2024-00058
• Device Sequence Number: 18374875
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2025

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-09-091-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/27/2025
• 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: 19 YR
• Patient Sex: Female