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 Paresthesia (4421); Implant Pain (4561)

Event Date 09/23/2022

Event Type  malfunction  

Event Description

Patient # (b)(6) index procedure was performed on (b)(6) 2022 with no intraoperative complications.Patient # (b)(6) mother contacted the hospital on a couple of occasions because the patient had an increase in her back pain and spasms.The episodes included bilateral worse on the right than on the left back spasm with some transient paresthesia in both of her feet.A ct scan that was completed on (b)(6) 2022 showed the right l4 screw is through the anterior cortex which may be contributing to symptoms.Revision surgery was performed on (b)(6) 2022 where a smaller implant was used (mid-c 95).

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) index procedure was performed on (b)(6) 2022 with no intraoperative complications.Patient # (b)(6) mother contacted the hospital on a couple of occasions because the patient had an increase in her back pain and spasms.The episodes included bilateral worse on the right than on the left back spasm with some transient paresthesia in both of her feet.A ct scan that was completed on (b)(6) 2022, showed the right l4 screw is through the anterior cortex which may be contributing to symptoms.Revision surgery was performed on (b)(6) 2022 where a smaller implant was used (mid-c 95).No report of patient harm or complications was received.Risk assessment the risk of late screw misplacement is a known risk that was assessed and recorded by the product risk management file.The event of misplaced screw in pedicle is addressed in the ifu (dms-766 rev u) as potential risks associated with the mid-c system.The rate of screw protrusion is 0.55%.At the time of this report, the incident rate for screw misplacement/migration was 2.8% and is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (0.2%-13%) (cer dms-727 rev u).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD.; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 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: 15678472
• MDR Text Key: 307081583
• Report Number: 3013461531-2022-00054
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/27/2022

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: AFS-125-050
• Device Lot Number: AF-03-079-21
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/27/2022
• Date Device Manufactured: 08/18/2021
• 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): Required Intervention
• Patient Sex: Female