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

Model Number MID-C 125

Device Problem Break (1069)

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

Event Date 03/23/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 apifix was notified that patient (b)(6) reportedly came into the clinic during the week with a rod fracture and a lenke 5 curve.The patient was completely asymptomatic.No injury or specific event.According to the reporter, "sounds like the family wants to proceed with rod exchange.".

Manufacturer Narrative

Investigation: 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.Surgeon, information analysis: patient (b)(6) index procedure performed on (b)(6) 2022 on (b)(6) 2024 apifix was notified that patient (b)(6) reportedly came into the clinic during the week with a rod fracture and a lenke 5 curve.The patient was completely asymptomatic.No injury or specific event.According to the reporter, "sounds like the family wants to proceed with rod exchange." on (b)(6) 2024 additional information was received.'this patient is scheduled for surgery sometime in may/june.Planning on a rod exchange.I do not have any details on how the rod broke, just that the patient is asymptomatic.We should have no problem getting the rod back for assessment!' risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk assessment.Implant breakage is addressed in the ifu (dms-4472 rev g, dms-766 rev u) as potential risks associated with the mid-c system and spinal surgery generally.The risk of broken rod - implant breakage has been assessed and found to be acceptable (dms#777 rev s hazard id 106- mechanical failure resulting in breakage of rod) the risk has been quantified, characterized, and documented as acceptable within full risk assessment.Revision surgery is scheduled for sometime in (b)(6) 2024, after which the subject device is expected to be returned to manufacturer where a failure analysis will be conducted.Once additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

On (b)(6) 2024 the patient was revised, during which a new rod (mid-c 115) was implanted.A new extender and a polyaxial screw were replaced as well (previously implanted poly screw remained in t10, & a new poly screw was implanted in t11)).Original apifix screw remained in l3.No report of patient complications/harm was received.

• 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: 19149938
• MDR Text Key: 341127524
• Report Number: 3013461531-2024-00019
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-01-069-21
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2024
• Initial Date FDA Received: 04/21/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/05/2024
• Date Device Manufactured: 06/14/2021
• 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 Sex: Female