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

Model Number MID-C 125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Asymmetry (4573)

Event Date 08/09/2023

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 was performed on (b)(6) 2019.On (b)(6) 2023 apifix was notified that patient (b)(6) is scheduled for revision surgery on (b)(6) 2023 due to the device reaching its maximum elongation and the patient's curve at 40°.According to the doctor, the girl grew in height and the implant has now reached its maximum elongation.On (b)(6) 2023 the revision procedure occurred, during which the mid-c 125 was replaced with a new mid-c 125.No report of patient harm/complications was received.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of curve progression has been assessed and found to be acceptable.The current rate for all relevant criteria (curve progression, insufficient curve correction, imbalance) 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 explanted device is not being returned to manufacture for analysis.Apifix is closing this complaint at this time, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If new relevant information is made available, apifix will update the complaint record and file a follow up medwatch report.

Event Description

On (b)(6) 2023 apifix was notified that patient (b)(6) is scheduled for revision surgery on (b)(6) 2023 due to the device reaching its maximum elongation and the patient's curve having progressed to 40°.According to the doctor, the girl grew in height and the implant has now reached its maximum elongation.

• 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: 17688616
• MDR Text Key: 322695348
• Report Number: 3013461531-2023-00039
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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-03-01-19
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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: 20 YR
• Patient Sex: Female