MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM; SPINE POLY-AXIAL PEDICLE SCREW

Model Number 03.52.322

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 july 2022: lot 2123283: (b)(4) items manufactured and released on 12-july-2021.Expiration date: 2026-06-27.No anomalies found related to the problem.To date, 33 items of the same lot have been sold without any similar reported event during the period of review.

Event Description

The top right side screw (l4) was displaced laterally about a week post-primary.The surgeon revised 2 screws and the rod (6x35 screws and 35mm rod).The surgeon suspects poor bone quality as the reason.The screw was initially well placed using the myspine drill guides.

• Brand Name: PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
• Type of Device: SPINE POLY-AXIAL 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: 15174142
• MDR Text Key: 297342019
• Report Number: 3005180920-2022-00605
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.52.322
• Device Catalogue Number: 03.52.322
• Device Lot Number: 2123283
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2021
• 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 Sex: Female