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 Unspecified Infection (1930)

Event Date 07/19/2022

Event Type  Injury  

Event Description

Patient # (b)(6) (clinical study patient (b)(6)) index surgery was performed on (b)(6) 2021.On (b)(6) 2022 apifix received an email from the mother of patient (b)(6), in which she describes: on (b)(6) 2022, the patient alerted her mother to a lump on her back near the upper part of the hardware.At the time the lump felt like it was 'deep within the tissue and hard'.  one week later a similar lump developed at the lower part of her incision near the lower part of the hardware.On (b)(6) 2022 the patient was examined by the surgeon where he did a local clean out (in office) and started the patient on antibiotics.

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: patient #(b)(6) (clinical study patient (b)(6)) index surgery was performed on (b)(6) 2021.On (b)(6) 2022, the patient alerted her mother to a lump on her back near the upper part of the hardware.At the time the lump felt like it was 'deep within the tissue and hard'.  one week later a similar lump developed at the lower part of the patient's incision near the lower part of the hardware.On (b)(6) 2022 the patient was examined by the surgeon where he did a local clean out (in office) and started the patient on antibiotics.On (b)(6) 2022 the patient was brought back to the operating room where the surgeon removed the apifix device due to dehiscence of her wound and infection.The patient had the implant for one year and one month.Risk assessment: the risk of late infection is a known risk that was assessed and recorded by the product risk management file.The risk of late infection has been assessed and found to be acceptable.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 event of wound complication is addressed in the ifu as potential risks associated with the mid-c system.The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Corrective action: following the 2019 pms report, apifix opened a capa to address an increase in late infection complaints.As part of the capa the company took the following actions: performed a vast literature search to identify the late infection rate reported in the literature.Investigated production lots associated with late infection.The compared antibiotic protocol used between centers was evaluated.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 cer 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.The company communicated these findings of applying vancomycin powder before wound closure to the surgeons and is continuing to follow the rate of late infection complaints.

Manufacturer Narrative

Return analysis: upon receiving the explanted devices at orthopediatrics in warsaw, in, the devices were cleaned and sterilized.The devices were photographed and analyzed.There were no obvious defects with the devices.Spherical rings had no obvious signs of wear.The polyaxial ring in the base component had one scratch of unknown origin.It is noted that the distal screw is absent and that the distal screw could not be removed by the surgeon.It does not appear that the device had any contribution to the need for explantation.The wear assessment of the retrieval analysis was not performed as the removal had an obvious failure mode of infection and is therefore exempt from the retrieval analysis.

• 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: 15223279
• MDR Text Key: 297860620
• Report Number: 3013461531-2022-00038
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

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: MUS-125-050
• Device Lot Number: AF-02-004-20
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• 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
• Patient Age: 15 YR
• Patient Sex: Female