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 Problems Unspecified Infection (1930); Implant Pain (4561)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Investigation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Patient removal surgery: the implant was removed due to pain.Culture swabs returned positive for infection by proprioni.Corrective action: the company decided to open (b)(4) to address late infection issue as part of the capa the company: performed a vast literature search to identify the late infection rate reported in the literature ((b)(4)).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 ((b)(4)).The company communicated these findings of applying vancomycin powder before wound closure to the surgeons ((b)(4)) and is continuing to follow the rate of late infection complaints.The present case was before the company's capa and regardless the surgeon does not use vancomycin antibiotics in any of the implantations.Risk assessment: the risk of pain is a known risk that has been assessed and found to be acceptable (dms#: (b)(4) rev q1).Event of pain addressed in the ifu warnings and precautions section: "metallic implants can loosen, fracture, corrode, migrate, or cause pain".Late-onset infection is a known risk that was assessed and recorded by the product risk assessment (b)(4) rev q hazard id 21.5 this complaint does not change the occurrences rate.The rates of late infection in surgeries where vancomycin was not used is 4.07% and 0.6% when used.The rate is well within the literature (0.2%-12.5% ,cer 727 rev t).The company is continuing to monitor late-infection complaints.

Event Description

On (b)(6) 2021, the distributor reported that the surgeon is a plan to perform a removal surgery on (b)(6) 2021.The patient complaint of pain.

• 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: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 11502792
• MDR Text Key: 240589564
• Report Number: 3013461531-2021-00011
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2021

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: No Information
• Device Expiration Date: 11/25/2020
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-01-15
• Initial Date Manufacturer Received: 02/21/2021
• Initial Date FDA Received: 03/17/2021
• Date Device Manufactured: 11/25/2015
• 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