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

Model Number MID-C 125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

On (b)(6) 2023, during imast (international meeting on advanced spine techniques), a professor notified an apifix representative that (b)(6) (index procedure performed on (b)(6) 2020) had the implant removed 18-21 months post-op due to a late infection of p.Acnes.It was vancomycin was not used during the index procedure.Apifix reminded the reporter the rationale of using vanco and alike during index surgery and also of apifix's work with an infection specialist done in the past.

Manufacturer Narrative

Production process analysis: 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.User (surgeon and patient) information analysis: on(b)(6) 2023, during imast (international meeting on advanced spine techniques), a professor notified an apifix representative that (b)(6) index procedure on (b)(6) 2020 had the implant removed 18-21 month post operative due to a late infection of p.Acnes.Risk assessment the risk of late infection is a known risk that was assessed and recorded by the product risk management file.The current late infection rate is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report) the risk of infection is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally the risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Following the 2019 pms report (dms- 5880), the company decided to open capa02-19 to address an increase in late infection complaints.As part of the capa the company: performed a vast literature search to identify the late infection rate reported in the literature (dms-6466).Investigated production lots associated with late infection - the compared antibiotic protocol used between centers.Received consultation by an infection specialist the capa investigation did not identify a manufacturing problem with implants used in patients that developed a late infection and the late infection rate noted was within the rate reported in the literature.The company did however identify that sites applying vancomycin powder before wound closure have a significantly lower rate of late infection complaints.The use of vancomycin powder was also supported by the infection specialist consultation (dms-6466) the company communicated these findings of applying vancomycin powder before wound closure to the surgeons (dms-6009) and is continuing to follow the rate of late infection complaints.On (b)(6) 2022 apifix ltd.Added the next recommendation to the mid-c system ifu (dms#766 rev u1):  "it is recommended that surgical site infection prevention measures should include applying localized antibiotic before wound closure.The antibiotic should be broad enough spectrum to be efficient on propionibacterium acnes or other common bacteria known to have been responsible for late site infections in your facility." infection can occur as a result of contamination during surgery from the environment, patient skin or surgeon.Vancomycin was not applied in the present case.Apifix reminded the reporter the rationale of using vanco and alike during index surgery and also of apifix's work with an infection specialist done in the past.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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: 16767837
• MDR Text Key: 313561899
• Report Number: 3013461531-2023-00011
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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: AFS-125-050
• Device Lot Number: AF-10-01-19
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Date Device Manufactured: 11/13/2019
• 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): Required Intervention