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

Model Number MID-C 125

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

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.Patient #(b)(6) index procedure was performed on (b)(6) 2022.On (b)(6) 2023 apifix was notified that patient #(b)(6) (index procedure on (b)(6) 2022), although having good curve correction, has the mid-c 125mm implant at full distraction.Surgeon decided to replace the apifix screw into t12 (one level up), so there is more distraction possible with continuous curve correction.Revision surgery occurred on (b)(6) 2023.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 mechanical failure of the mid-c mechanism resulting in patient re operation due to inadequate curve correction is an known risk, and has been characterized and documented as acceptable within full risk assessment.Medical device problem code used was: 3191 appropriate term/code not available.The mid-c system is a ratchet-based self-expandable rod designed to passively increase its length and subsequently maintain its length as the child bends in the corrective direction and also accommodate the natural growth of the spine of young children.In this case the implant (rod) was at its maximum elongation.The appropriate code which isn't available is 'device at maximum elongation'.

Event Description

On 05-jun-2023 apifix was notified that patient #(b)(6) (index procedure on (b)(6) 2022), although having good curve correction, has the mid-c 125mm implant at full distraction.Surgeon decided to replace the apifix screw into t12, so there is more distraction possible with continuous curve correction.

• Brand Name: MID-C 125
• 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: 17245438
• MDR Text Key: 318271553
• Report Number: 3013461531-2023-00025
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: AFS-125-050
• Device Lot Number: AF-01-069-21
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Date Device Manufactured: 04/19/2021
• 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 Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female