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
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00120
• Device Sequence Number: 17770954
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown