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

Model Number MID-C 125

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, apifix was notified that patient (b)(6) (pas #091-a005) has a broken implant.2 year follow-up x-rays showed implant breakage at end of way.The patient, a high level gymnast, was asymptomatic, no pain.

Manufacturer Narrative

Production process analysis: 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.User (surgeon and patient) information analysis: on (b)(6) 2023, apifix was notified that patient (b)(6) (pas #091-a005) has a broken implant.2 year follow-up x-rays showed implant breakage at its 'end of way'.The patient, a high level gymnast, was asymptomatic, no pain.The patient is reported to have grown 2 inches and gained 25 lbs.Implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis.Inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).The risk for breakage due to the above increases when the implant reaches its maximal elongation.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of broken rod has been assessed and found to be acceptable.The current implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.On (b)(6) 2023, it was reported that the patient is having no pain or issues and wants to put off surgery for now.  they are following up in the summer to discuss removal/revision options.Once additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: on (b)(6) 2023 patient #(b)(6) underwent implant removal. 'patient (b)(6) was seen on (b)(6) 2023 by dr.(b)(6) for her two year follow up.At presentation patient reported no pain and everything appeared normal.During the appointment, as is standard, an x-ray was performed.The x-ray showed the apifix device was fractured.After speaking with the patient and guardians, it was decided that the apifix device would be removed and not replaced.The patient had the device removed on (b)(6) 2023.No report of patient pain/complications was received.The explanted device is expected to be returned to the manufacturer and will be evaluated.Following the evaluation, once new information comes to light, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was fractured near the mid-point of the pole.The fracture mode is unknown because the fracture plane was worn smooth, removing indicators of fracture type.The fracture plane and external surfaces were worn, indicating that the device remained implanted for some time post fracture event.The wear analysis portion of retrieval and analysis protocol (b)(4) was not conducted because the cause of failure was obvious, device fracture.

• Brand Name: MID-C 125
• Type of Device: 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: 16663348
• MDR Text Key: 313166869
• Report Number: 3013461531-2023-00009
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

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 Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-02-004-20
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 03/07/2023; 03/07/2023
• Supplement Dates FDA Received: 07/06/2023; 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female