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

Model Number MID-C 105

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 01/28/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record confirmed that the device was manufactured and tested according to relevant procedure and shipped according to manufacturer's specifications.On 01-dec-2022, apifix was notified that patient (b)(6) has been experiencing pain over the past months and occasionally hears a 'cracking' sound coming from the device, which has been annoying her.The reporter provided patient photos, x-rays, and a recent ct of the patient.Images demonstrate that the screw in the axial plane has breached the medial wall and is sitting in the canal.This is most likely the cause of the patient's pain.Screw misplacement at the index surgery may lead to migration, curve progression, or pull-out over time.Since optimal screw placement, in the middle of the pedicle, is a complex task, especially in the upper part of the spine where the pedicles are very small, this problem is mainly related to the surgeon's skills and the patient's anatomy.In addition, screw migration may also result from an infection.The event may be associated with pain.The company started to use an upper extender in 2017 in part to achieve better anchorage of the device's upper fixation point and lower the migration rate.  this event occurred prior to the use of extenders.Reoperation events are a known risk that was assessed and recorded by the product risk assessment dms-777 rev r; this complaint does not change the occurrences rate.The event of implant migration is addressed in the ifu (dms-766 rev u) as potential risks associated with the mid-c system and spinal surgery generally at the time of this report, the incident rate for screw misplacement/migration was is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report.On 25-dec-2022 apifix followed up with the reporter for any updates or new information.The reporter updated that the plan is to remove the patient's device, but the surgery date has not yet been set.

Event Description

On 01-dec-2022, apifix was notified that patient (b)(6) has been experiencing pain over the past months and occassionally hears a 'cracking' sound coming from the device, which has been annoying her.The reporter provided patient photos, x-rays, and a recent ct of the patient.

Manufacturer Narrative

On 02-feb-2023 apifix was notified that patient # (b)(6) underwent implant removal surgery on (b)(6) 2023.

• Brand Name: MID-C 105
• 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: alan vaisman ; 1 hacarmel st.; kochav yokneam bldg; yokneam ellit, 20692-07 ; IS 2069207
• MDR Report Key: 16066163
• MDR Text Key: 308490509
• Report Number: 3013461531-2022-00067
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MID-C 105
• Device Catalogue Number: AFS-105-040
• Device Lot Number: AF-08-01-16
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Date Device Manufactured: 08/03/2016
• 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