MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X50MM; PEDICLE SCREW IMPLANT

Catalog Number 03.52.325

Device Problem Malposition of Device (2616)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 october 2018.Lot 1621164: (b)(4) items manufactured and released on 02 february 2017.Expiration date: 2022-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved and revised: lot 164296: (b)(4) items manufactured and released on 25 july 2016.Expiration date: 2021-07-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

Patient came in complaining of pain 2 months after primary.The surgeon thought the screws may have been fractured.Upon opening the patient, the surgeon determined that the screws were not fractured.The surgeon was displeased with screws placement.The surgeon revised 2 screws.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X50MM
• Type of Device: PEDICLE SCREW IMPLANT
• 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: 8023978
• MDR Text Key: 125649184
• Report Number: 3005180920-2018-00852
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857607
• UDI-Public: 07630030857607
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 03.52.325
• Device Lot Number: 1621164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2017
• 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