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 Wound Dehiscence (1154)

Event Date 09/19/2023

Event Type  Injury  

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.Patient #(b)(6)underwent removal surgery on (b)(6) 2023 following screw breakage and 1 month in a corset brace (ref: (b)(4)).On (b)(6) 2023, during monitoring as part of the pas study, apifix was made aware that patient #(b)(6)) reportedly had wound dehiscence following the (b)(6) 2023 removal.Dehiscence was classified as 'mild', 1-1.5cm wound dehiscence distally without any evidence of active infection.Patient was treated (outpatient) with wet to dry wound dressings.As of (b)(6) 2023, issue had reportedly been resolved with no further treatment required.Apifix believes that dressing and local wound care may qualify as medical treatment to prevent a more aggressive intervention, especially as wound dehiscence is a common way that later-term wound infections often become apparent, and in an abundance of caution, apifix is reporting this event.Risk assessment: early infections (e.G, wound complications) are usually surgery related and resolve without sequala following conservative treatment.The risk of wound dehiscence is a known risk.This risk has been assessed and found to be acceptable per the company cer.The event of wound dehiscence is addressed in the ifu in the 'potential risks associated with the mid-c system and spinal surgery generally' section.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.

Event Description

Apifix was made aware that patient #(b)(6) reportedly had wound dehiscence following their implant removal.Patient was treated (outpatient) with wet to dry wound dressings.Issue had reportedly been resolved as of (b)(6) 2023.

• Brand Name: MID-C 125
• 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: 18208048
• MDR Text Key: 328959459
• Report Number: 3013461531-2023-00056
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MID-C 125
• Device Catalogue Number: MUS-125-050
• Device Lot Number: AF-03-080-21
• Date Manufacturer Received: 11/03/2023
• Date Device Manufactured: 05/06/2021
• 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 Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female