MAUDE Adverse Event Report: APIFIX LTD. MID-C 105; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 105

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

Production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Surgeon information and analysis: patient (b)(6) index procedure was performed on (b)(6) 2016. on 23-aug-2022, a distributor notified apifix that patient (b)(6) is being scheduled for an implant removal due to persistent pain and curve progression.Apifix reached out to the surgeon for additional information which was provided.The surgeon provided the latest patient x-rays and ct images which showed that the upper screw has migrated cranially and towards the spinal canal.Apifix clinical affairs reviewed the available information from the patient's file.Patient (b)(6) was initially treated out of indication, specifically the patient's pre-op cobb angle was measured at 70° with lateral side-bending measured at 42° (mid-c ifu  - 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).Immediately after the index surgery, the patient's curve was reduced to 33° and at 12 weeks it had progressed to 44°.  the curve progressed and the patient is concerned about the size of the curvature.The surgeon's plan is to revise the patient to fusion.On 25-aug-2022 the surgeon provided additional information and intraoperative photos of the implant.During the explantation of the device it was discovered that the implant had broken despite not being visible in imaging.There were signs of debris all around the area of the implant and soft tissues showed signs of inflammation.It was decided not to reinstrument the patient at the same procedure.  apifix has requested the implant back for further analysis.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.At the time of this report, the incident rate for screw misplacement/migration & the incident rate for 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 risk of broken rod and the risk of the screw misplacement/migration have been assessed and found to be acceptable.The risks have been quantified, characterized, and documented as acceptable within a full risk assessment.

Event Description

Patient (b)(6) index procedure was performed on (b)(6) 2016.On 23-aug-2022, apifix was notified that the surgeon intends on removing patient (b)(6) implant due to "persistent pain and progression beyond the correction range.".

• Brand Name: MID-C 105
• 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 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: 15445356
• MDR Text Key: 306416063
• Report Number: 3013461531-2022-00045
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MID-C 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-07-01-15
• Date Manufacturer Received: 08/23/2022
• Date Device Manufactured: 08/30/2015
• 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 Sex: Female