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

Model Number MID-C 95

Device Problem Noise, Audible (3273)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notified that the patient #308 is scheduled for implant removal.On (b)(6) 2023.The patient reportedly hears a metallic sound coming from her back.

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, x-ray, information analysis: on (b)(6) 2023 apifix was notified that the patient #308 is scheduled for implant removal on (b)(6) 2023.The patient reportedly hears a metallic sound coming from her back. on (b)(6) 2023 apifix was further notified that on (b)(6) 2023 the patient's implant was removed due to a ratchet mechanism failure.Coorective 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: reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r this complaint does not change the occurrences rate.The risk of the ratchet malfunction has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.6).The total rate of ratchet malfunction for any reason is 1.60% the risks have been quantified, characterized, and documented as acceptable within full risk assessment.Upon return of the implant a failure analysis will be conducted.When further relevant information is identified with which to determine a cause, a supplemental report will be filed.

• 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: 16971014
• MDR Text Key: 315928048
• Report Number: 3013461531-2023-00015
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 05/21/2023

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 95
• Device Catalogue Number: AFS-095-030
• Device Lot Number: AF-10-01-17
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/21/2023
• Date Device Manufactured: 11/06/2017
• 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: 18 YR
• Patient Sex: Female