MAUDE Adverse Event Report: APIFIX LTD. MID-C 115; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 115

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

Patient Problem Wound Dehiscence (1154)

Event Date 01/31/2024

Event Type  Injury  

Event Description

During monitoring, as part of the pas study, apifix was made aware on 08-feb-2024 that patient (b)(6), index procedure performed on (b)(6) 2024, reportedly had  'superficial wound infection, wound dehiscence".A small amount of serous drainage from a tiny distal wound dehiscence. keflex was administered to the patient.

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.During monitoring, as part of the pas study, apifix was made aware on 08-feb-2024 that patient(b)(6), index procedure performed on (b)(6) 2024, reportedly had  'superficial wound infection, wound dehiscence".A small amount of serous drainage from a tiny distal wound dehiscence. keflex was administered to the patient.On (b)(6) 2024 apifix was notified that patient (b)(6) underwent revision surgery.According to the report, patient underwent their initial apifix procedure on (b)(6) 2024.Following the apifix placement, the patient returned to clinic with some draining from the bottom of the incision.The patient was reported to have wound drainage and partial wound dehiscence.The patient was placed on keflex for 7 days.Due to persistent wound drainage and dehiscence, the patient then underwent a washout and apifix rod/extender revision on (b)(6) 2024.During the wash out, it was noted that the skin and subcutaneous tissue was purulent and there was a hole at the distal aspect of the fascia with exposed hardware.The apifix rod was removed and a new rod was placed.Cultures were taken of the surrounding tissue and lab results are showing e.Coli, signifying an infection.  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.The explanted device has been returned to the manufacturer and will be evaluated.Following the evaluation, if new pertinent information comes to light, then a supplemental medwatch report will be submitted.

• Brand Name: MID-C 115
• 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: 18843971
• MDR Text Key: 336956427
• Report Number: 3013461531-2024-00012
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290018128039
• UDI-Public: 07290018128039
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MID-C 115
• Device Catalogue Number: MUS-115-040
• Device Lot Number: AF-09-091-21
• Date Manufacturer Received: 02/08/2024
• Date Device Manufactured: 05/04/2022
• 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 Sex: Female