MAUDE Adverse Event Report: APIFIX LTD. MID-C 95; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 95

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 09/20/2023

Event Type  malfunction  

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: patient (b)(6) index procedure was performed on (b)(6) 2015 on 20-sep-2023 apifix was notified that patient (b)(6) is scheduled for an upcoming removal procedure on (b)(6) 2023 due to 'hardware breakage'.Per the reporter, additional details, including patient identifier, would be provided after the surgery.Apifix followed up with the surgeon for additional information which was received.According to the surgeon, the issue was a ratchet malfunction."after stretching, the patient had acute patin in her back, severe pain lasted 2 weeks, new squeaking sound with moving." according to the surgeon, the removal procedure went well.No report of patient harm/complications was received.The surgeon stated that infection was not seen.Corrective action: ratchet malfunction (resulting in a backup of the distraction) can result from physical trauma, practicing high-demand sports, and tissue growth inside the ratchet mechanism.Ratchet malfunction may be a coincidental finding and may also be reported together with pain/curve progression/noise.The company took several actions to mitigate ratchet malfunction: eco-13, the ratchet flat spring component was changed to a thicker spring (from 0.15 to 0.25mm).Eco-59, addition of a stopper pin to prevent the pole from dislocating from the base and inherit from the design to prevent the collapse of the ratchet.In march 2020, a highlight of the risk associated with practicing high-demand sports was added to the mid-c training presentation.The company continues to monitor the effectiveness of the mitigations.Risk assessment: pain is a known risk.Pain associated with scoliosis is well described in the literature regardless of having corrective surgery.Pain can also be a transient complaint associated with the surgical procedure or be secondary to device failure, infection/inflammation, curve progression, screw pull-out, loosening, migration, protrusion, and prominence.This risk has been assessed and found to be acceptable.Pain is addressed in the ifu as a warning and as potential risks associated with the mid-c system and spinal surgery generally.Reoperation events are a known risk that was assessed and recorded by the product risk assessment.The risk of the ratchet malfunction has been assessed and found to be acceptable.The risks have been quantified, characterized, and documented as acceptable within full risk assessment.Apifix has not been informed if the device is being returned for analysis.If the device is returned, when further relevant information is identified with which to determine a cause, a supplemental report will be filed.

Event Description

On 20-sep-2023 apifix was notifed that patient #59 was scheduled for an upcoming removal procedure on (b)(6) 2023 due to ratchet malfunction.

Manufacturer Narrative

Engineering analysis of returned device: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.During the inspection, the device's ratcheting mechanism did not appear to be functioning properly.Specifically, when the control pin was in ratchet position (arrow of control pin aligned with arrow on device body) the device should "click" upon lengthening and allow no shortening.However, upon applying an axial load the device could be easily shortened.The exact cause of this malfunction could not be investigated because the internal mechanism is sealed by permanent closure (weld).There were no obvious manufacturing or design defects which contributed to the failure.

• Brand Name: MID-C 95
• Type of Device: 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: 17955409
• MDR Text Key: 325909053
• Report Number: 3013461531-2023-00048
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 95
• Device Catalogue Number: AFS-095-030
• Device Lot Number: AF-03-01-14
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2014
• 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