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

Model Number MID-C 125

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

On 07-dec-2022, apifix was notified that patient#: (b)(6) underwent a revision procedure on (b)(6) 2022 for reasons not specified.Upon following up with the surgeon for additional information, it was reported that there was a problem with the distal extender screw resulting in a kite angle problem.

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 07-dec-2022, apifix was notified that patient#: (b)(6) underwent a revision procedure on (b)(6) 2022 for reasons not specified.Upon following up with the surgeon for additional information, the following notes from the revision surgery were provided: 'there was a problem with the distal extender screw resulting in a kite angle problem, adding that the revision was necessary because a correct kite angle was not achieved during the first operation on (b)(6) 2022 due to a far leterally inserted lower extender screw.Shortly before the planned reoperation, the screw had also broken off.The patient was sympthom free.The screw could be safely and solidly inserted medially and the extender was exchanged.The surgeon and patient are very satisfied with the final result.' clinical affairs reviewed the patient's index procedure post-op x-rays which demonstrated that the extender wasn't positioned per the company's surgical technique (the patient extender angle was measured at 35°; the surgical technique states that the extender angle should be 5-15° compared to the mid-c rod).The company's incident rate of extender misalignment is 2.70%.The risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.

• 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 st.; kochav yokneam bldg; yokneam ellit, 20692 07; IS 2069207
• Manufacturer Contact: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16100734
• MDR Text Key: 308636357
• Report Number: 3013461531-2022-00069
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-09-092-21
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/05/2023
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: No
• 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: 16 YR
• Patient Sex: Female