MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM

Model Number 03.52.336

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 february 2021: lot 1720188: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-08.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: pedicle screw 03.52.337 enh.Poly-axial pedicle screw - cannulated 7x40mm (k141988) lot.1923616.Batch review performed on 22 february 2021: lot 1923616: (b)(4) items manufactured and released on 4-feb-2020.Expiration date: 2025-01-14.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: pedicle screw 03.52.324 enh.Poly-axial pedicle screw - cannulated 6x45mm (k141988) lot.1921212.Batch review performed on 22 february 2021: lot 1921212: (b)(4) items manufactured and released on 3-jun-2019.Expiration date: 2024-05-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event(two devices of this lot were reported in this compliant).Additional implant involved: pedicle screw 03.52.325 enh.Poly-axial pedicle screw - cannulated 6x50mm (k141988) lot.1923843.Batch review performed on 22 february 2021: lot 1923843: (b)(4) items manufactured and released on 24-jan-2020.Expiration date: 2025-01-06.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: pedicle screw 03.52.324 enh.Poly-axial pedicle screw - cannulated 6x45mm (k141988) lot.1923135.Batch review performed on 22 february 2021: lot 1923135: (b)(4) items manufactured and released on 5-nov-2019.Expiration date: 2024-10-12.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: pedicle screw 03.52.430 enh.Bent rod ti 5.5x70mm (k141988) lot.1621109.Batch review performed on 22 february 2021: lot 1621109: (b)(4) items manufactured and released on 29-mar-2017.Expiration date: 2022-03-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event (two devices of this lot were reported in this compliant).

Event Description

The patient came in 5 months after the primary surgery due to signs of an infection and the pathogen is methicillin-susceptible staphylococcus aureus.The surgeon performed a washout and revised the 3 cann.Pedicle screws 6x45mm + nut (1x) sterile, 1 cann.Pedicle screw 7x35mm + nut (1x) sterile, 1 cann.Pedicle screw 7x40mm + nut (1x) sterile, 1 cann.Pedicle screw 6x50mm + nut (1x) sterile, and 2 bent rods ti r200 5.5x70mm - sterile.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11453396
• MDR Text Key: 239395110
• Report Number: 3005180920-2021-00189
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857744
• UDI-Public: 07630030857744
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 03.52.336
• Device Catalogue Number: 03.52.336
• Device Lot Number: 1720188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2017
• 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