MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM; SPINE PEDICLE SCREW CANNULATED

Model Number 03.52.323

Device Problem Fracture (1260)

Patient Problem Implant Pain (4561)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 february 2023 lot 1820933: (b)(4) items manufactured and released on 07-sep-2018.Expiration date: 2023-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation.The case was discussed by the r&d spine director with the surgeon and a suspected pseudoarthrosis with the absence of fusion is, with high probability, the reason for the breakage.Clinical evaluation performed by medical affairs department.About 3.5 years after primary lumbar stabilization surgery, an extension of the construct becomes necessary, most probably to include adjacent levels, due to disease progression.During the extension surgery, one of the original screws is found broken.This may happen, in very rare cases, when the permanence in situ of the screws is prolonged for several years and there may have been delayed fusion.In these cases, fatigue fracture can occur.This is a possible long-term adverse event following spinal fusion surgery, described in literature and in the instructions for use leaflet.It does not necessarily imply a defect in the implant.No clinical consequence for the patient is to be expected at this stage.

Event Description

The patient came in reporting pain during a post-op appointment.The surgeon took x-rays and decided to schedule an additional surgery at about 3 years 7 months after the primary to extend the patient's construct.During the additional surgery, it was observed that the l5 must mc screw was broken (tulip head came off).The surgeon could not remove the rest of the screw and proceeded to extend the patients construct.There was no delay and the surgery was completed successfully.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
• Type of Device: SPINE PEDICLE SCREW CANNULATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16459487
• MDR Text Key: 310425061
• Report Number: 3005180920-2023-00120
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 03.52.323
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1820933
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2018
• 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