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

Device Problem Break (1069)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 apifix was notified that an unspecified patient is scheduled for removal surgery on (b)(6) 2023 ,due to implant breakage (unspecified).According to the reporter, the patient went through one previous revision due to breakage.The plan is to convert the patient to fusion on (b)(6).

Manufacturer Narrative

User (surgeon and patient) information analysis: on (b)(6) 2023 apifix was notified that an unspecified patient is scheduled for removal surgery on (b)(6) 2023, due to implant breakage (unspecified).According to the reporter, the patient went through one previous revision due to breakage.The plan is to convert the patient to fusion on (b)(6).Apifix followed up with the distributor for additional information, however no additional information has been received other than the planned date for the patient's fusion has been pushed to (b)(6) 2023.Risk assessment: implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism has been assessed and found to be acceptable.The implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report.Apifix is continuing to investigate this event.When additional information comes to light, then a supplemental medwatch report will be submitted.

• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; yokneam ellit, 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: 18027616
• MDR Text Key: 326798528
• Report Number: 3013461531-2023-00051
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 10/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1