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

Model Number MID-C 125

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notified that patient #565 is scheduled for removal surgery on (b)(6) 2023 before going to fusion.

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 #565 index procedure was performed on (b)(6) 2021.The patient was treated outside the indications for use (non-ais) knowingly by the surgeon after consultation with the patient's family (i.E., not within the approved indications, the patient's scoliosis is syndromic due to myelomeningocele and not ais.) patient #565 underwent a revision surgery on (b)(6) 2022 due to screw pull-out and spinal imbalance.During the surgery a sublaminar band was placed at l2 and implant was locked.On (b)(6) 2023 apifix was notified that patient #565 is scheduled for implant removal surgery on (b)(6) 2023 before converting to fusion. reason for the re-op were not provided.Apifix has followed up with the reporter for more information.Despite multiple follow-ups for additional information, apifix has been unable to obtain additional information regarding the circumstances surrounding this event.Apifix is continuing its investigation of this event.When new information is received with which to determine a cause for the reported event, apifix will file a follow-up mdr.Although no allegation of deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an apifix device was received, this event is leading to a removal surgery.Apifix believes that subjecting a patient to another round of anesthesia and additional surgery carries inherent risks, and in an abundance of caution, apifix is reporting this as an adverse event.

• 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: 17214992
• MDR Text Key: 317987929
• Report Number: 3013461531-2023-00022
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128046
• UDI-Public: 07290018128046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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: MUS-125-050
• Device Lot Number: AF-01-069-21
• Date Manufacturer Received: 06/01/2023
• 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 Outcome(s): Other
• Patient Age: 14 YR
• Patient Sex: Male