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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

On 11-jan-2024 apifix was notified that patient (lenke 2, dob 2003) is scheduled for planned explantation surgery on (b)(6) 2024.The reporter has asked for a set (tools) to be sent in advance for the removal surgery.The reporter further said that he has asked for patient details, date of index surgery, reason for removal, and is awaiting feedback.Apifix followed up with the reporter to request, following the removal procedure, that the implants be returned to apifix for evaluation, and if the device is not being returned, to provide a rationale why.On 22-jan-2024 apifix followed up with the reporter requesting additonal information and whereabout of the removed device, if the device to be returned for analysis.The reporter responded that the surgery was ok, there was no report of any patient harm or complications.The device is not being returned to the manufcaturer.No additional information had been received.The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.Apifix has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

On 11-jan-2024 apifix was notified that patient (lenke 2, dob 2003) is scheduled for planned explantation surgery on (b)(6) 2024.

• Brand Name: MID-C
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel street; yokneam elit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 18668847
• MDR Text Key: 335826800
• Report Number: 3013461531-2024-00003
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other