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

Model Number MID-C 105

Device Problem Fracture (1260)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

A review of dhr has demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.A review of the patient's x-rays since the index surgery demonstrates implant breakage due of the upper screw insertion in the wrong trajectory by the surgeon, locking the polyaxiality of the joint.Since the surgeon training presentation that was in use on (b)(6) 2015, have not contained explanation regarding the screw trajectory, the company update the training presentation on (b)(6) 2017 and since then no incidents of device failure due to screw trajectory were reported.The risk of device failure due to wrong screw trajectory, post the relevant mitigation, has been assessed and found to be acceptable (b)(4) rev q1 hazard id (b)(6)).

Event Description

On (b)(6) 2020 the surgeon informed the company that the patient had revision surgery due to implant breakage (screw and rod breakage) as indicated in the x-ray.

• Brand Name: MID-C 105
• 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: 10325741
• MDR Text Key: 200419472
• Report Number: 3013461531-2020-00005
• Device Sequence Number: 1
• Product Code: QGP
• UDI-Device Identifier: 07290014993051
• UDI-Public: 7290014993051
• 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: Physician
• Type of Report: Initial
• Report Date: 07/23/2020

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: 04/30/2020
• Device Model Number: MID-C 105
• Device Catalogue Number: AF105L
• Device Lot Number: AF 05-01-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2015
• 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