MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM; SPINE PEDICLE SCREW

Catalog Number 03.52.314

Device Problem Failure to Osseointegrate (1863)

Patient Problem Pain (1994)

Event Date 06/26/2023

Event Type  Injury  

Event Description

2 pedicle cannulated screws were found loose during revision surgery for patient's back pain (10 months post primary).Level l4-l5.

Manufacturer Narrative

Batch review performed on (b)(6), 2023: lot 2020775: (b)(4), manufactured and released on 25-may-2020.Expiration date: 2025-05-05.No anomalies found related to the problem.To date, (b)(4), of the same lot have been sold without any similar reported event in the period of review.Additional involved implant: batch review performed on (b)(6), 2023 on pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm (k141988) lot.2125837 lot 2125837: (b)(4), manufactured and released on 16-nov-2021.Expiration date: 2016-10-26.No anomalies found related to the problem.To date, (b)(4), of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
• Type of Device: SPINE PEDICLE SCREW
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17389620
• MDR Text Key: 319837517
• Report Number: 3005180920-2023-00540
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857461
• UDI-Public: 07630030857461
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.52.314
• Device Lot Number: 2020775
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2020
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG