MAUDE Adverse Event Report: APIFIX LTD MID-C 105L; POSTERIOR RATCHETING ROD SYSTEM,,,

Model Number MID-C 105

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

First evaluation: production process: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.Patient information : based on the distributer information the removal surgery was performed due to an infection.Corrective action: following the 2019 post market surveliance report (dms- (b)(4)), the company decided to open capa (b)(4) 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-(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 (dms-(b)(4)) the company communicated these findings of applying vancomycin powder before wound closure to the surgeons (dms-(b)(4)) and is continuing to follow the rate of late infection complaints.Risk assessment: late-onset infection is a known risk that was assessed and recorded by the product risk assessment dms-(b)(4) rev q hazard id 21.5 this complaint does not change the occurrences rate.We assume that in the present case vancomycin was not applied.The total rate of late infection is 3.96% (n=20).Of them, only 1 cases was when vancomycin was applied which is 0.2% (1/505).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

The patient had a removal surgery on (b)(6) 2021 due to an infection.

• Brand Name: MID-C 105L
• 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: 11683216
• MDR Text Key: 245984400
• Report Number: 3013461531-2021-00018
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/21/2022
• Device Model Number: MID-C 105
• Device Catalogue Number: AF105L
• Device Lot Number: AF 11-04-17
• Date Manufacturer Received: 03/25/2021
• Date Device Manufactured: 11/21/2017
• 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