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

Model Number MID-C 125

Device Problem Migration (4003)

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

Event Date 11/30/2023

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: patient #(b)(6) index procedure performed on (b)(6) 2022.On (b)(6) 2023 apifix was notifed that patient #(b)(6) underwent revision surgery on that day due to t6 screw pull-out.During the revision the polyaxial screws were replaced with bigger screws (7.0x35) and moved up one level (t4/t5 to t5/t6).A new mid-c and extender of the same size and type were replaced.The device is not being returned to the manufacturer for analysis and will remain with the patient.Patient requested to keep the implant.Clinical affairs reviewed images from the original surgery and from the pre-op (b)(6) 2023 and could not determine if the kite angle collapsed pulling the screw with it or vice versa.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of screw pullout has been assessed and found to be acceptable the current screw pullout 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.The event of screw pull-out (misplaced screws in pedicle/nut loosening from the pedicle screw & subsequent surgical interventions) is addressed in the ifu as potential risks associated with the mid-c system.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

Event Description

On (b)(6) 2023 apifix was notifed that patient #(b)(6) underwent revision surgery on that day due to screw pull-out.

• 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 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: 18390426
• MDR Text Key: 331583894
• Report Number: 3013461531-2023-00060
• Device Sequence Number: 1
• Product Code: QGP
• 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,Company Representative
• Reporter Occupation: Other
• Report Date: 12/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2023
• 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-01-069-21
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: 23 YR
• Patient Sex: Female