MAUDE Adverse Event Report: APIFIX LTD MID-C 125; POSTERIOR RATCHETING ROD SYSTEM,,

Model Number MID-C 125

Device Problem Fracture (1260)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

A review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.The x-ray demonstrates that the system reached its maximal elongation, which is the weakest point of the rod.Thus, pressure in this position, the transverse process below the implant may generate a force acting on the system that can cause the rod breakage.To protect against such force it is necessary to use the trial tool according to the detailed steps as described in the surgical technique guide.The surgery was performed in a minimal invasive approach (mis), which makes it quite challenging to verify that the surface below the implant is sufficiently clean from any soft or hard tissue before placing the implant.For this reason, the use of mis technique is not recommended by the company and the surgical technique instructs to perform the surgery with an open midline incision.At the time of this report (aug 2020), the company's incident rate due to implant breakage at maximal elongation is 0.93% and the overall for this category is 6.21%, which is well within the rate reported in the literature for this category ( 0.2%-15.5%) ( cer dms-727 rev r).The risk of the broken rod has been assessed and found to be acceptable (dms#777 rev q1 hazard id 1.8).Besides, the company has implemented corrective action resulting in an updated design of the mid-c 125 with elongation of 50 mm, having longer overlap between pole and base which mitigate against cases of maximal elongation.

Event Description

On (b)(6) 2020 the patient heard and felt a "snap" in her back while sitting down., the x-ray on (b)(6) 2020, demonstrated on implant breakage.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM,,
• Manufacturer (Section D): APIFIX LTD; 17 tehelet street; misgav business park; misgav, 20174 00; IS 2017400
• Manufacturer (Section G): APIFIX LTD; 17 tehelet street; misgav business park; misgav, 20174 00; IS 2017400
• Manufacturer Contact: adi prager ; 17 tehelet street; misgav business park; misgav, 20174-00 ; IS 2017400
• MDR Report Key: 10498627
• MDR Text Key: 205969303
• Report Number: 3013461531-2020-00007
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993068
• UDI-Public: 7290014993068
• Combination Product (y/n): Y
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 09/02/2020

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: 11/22/2022
• Device Model Number: MID-C 125
• Device Catalogue Number: AF125
• Device Lot Number: AF 11-05-17
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2017
• 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