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

Model Number MID-C 115

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

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 02-oct-2023 apifix was notified that patient (b)(6) is scheduled for revision surgery on (b)(6) 2023 due to implant breakage (rod).The plan is to replace to a new apifix device.On (b)(6) 2023 apifix was notified that the revision surgery was performed on that day, during which the broken implant (mid-c 115) was replaced with a new one (mid-c 125). the broken implant is expected to be returned to the manufacturer for analysis.Apifix clinical affairs reviewed the patient case file and identified that patient (b)(6) was treated out of indications for use.This patient had a cobb anlge of 57° with lateral bending 32° (mid-c ifu  - apifix is indicated for use in patients having a cobb angle of up to 60 degrees which reduces to less than or equal to 30 degrees on lateral side-bending radiographs) risk assessment: 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).Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism - [misuse > implant breakage] has been assessed and found to be acceptable.The 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 clinical evaluation report.The explanted device is expected to be returned to the manufacturer for analysis.Upon completion of the evaluations, when additional information comes to light, then a supplemental medwatch report will be submitted.

Event Description

On 02-oct-2023 apifix was notified that patient (b)(6) is scheduled for revision surgery on (b)(6) 2023 due to implant breakage (rod).The plan is to replace to a new apifix device.

Manufacturer Narrative

Return analysis: the explanted device was returned and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was obviously fractured in the pole component around the mid-point of the pole.It appears that post fracture the device remained implanted as the fracture plane, body, and side of pole showed signs of significant wear.The fracture plane was worn completely smooth from and thus fracture mode is not able to be identified.No wear was visibly observed on the spherical ring of the pole.Heavy wear was observed on the spherical ring of the base.

• Brand Name: MID-C 115
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; 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: 18027617
• MDR Text Key: 326804101
• Report Number: 3013461531-2023-00050
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 115
• Device Catalogue Number: AFS-115-040
• Device Lot Number: AF-11-01-18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• 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: 20 YR
• Patient Sex: Male