MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM; SPINE PEDICLE SCREW

Model Number 03.52.324

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

Patient Problem Bone Fracture(s) (1870)

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 4 october 2022: lot 2126415: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 2026-nov-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

The lower edge of the pedicle on both sides of l5 fractured during screw insertion in the cortical bone trajectory.On the left, the lower edge of the pedicle was slightly cracked, and on the right, the entire lower edge of the pedicle was cracked.Bone quality was normal.The surgeon used myspinemc guide.He did a 5mm under drill, then a 5mm tap with a guide wire, and then a 6 mm tap.One side still seemed to be fixed, so the screw was left as it was.The fracture on the other side was large and the larger screw was inserted into the pedicle screw trajectory.

Manufacturer Narrative

The item involved in the complaint has been returned on october 26th 2022.Visual inspection performed by r&d project manager.The reported issue seems to be associated more with the position of the screw than with the screw itself.Analyzing the myspine surgical planning report it can be observed that is mentioned a potential pedicle breaching in both the pedicles in l5 vertebra based on the users modifications between the revision zero and one of the planning.The event reported "the lower edge of the pedicle on both sides of l5 fractured during screw insertion in the cbt trajectory" is compatible with the warning reported in the myspine surgical planning report.

Manufacturer Narrative

Clinical evaluation performed by medical affairs director: this complaint refers to a lumbar stabilization surgery.The surgeon planned for a 6 mm screw (comparatively large) to be placed very near the edge of the pedicles: he was most probably seeking to give the best possible stability, using a cortical-based trajectory and the largest possible screw.The planning system warned that the screws were likely to breach the pedicle but, certainly for medical reasons, the surgeon decided to maintain the plan.The patient-specific guides were manufactured accordingly.In these conditions, one of the pedicles fractured but the screw was judged to be soundly placed anyway.On the other side, the fracture of the pedicle limited the stability of the screw and therefore the surgeon decided to follow the traditional divergent path.No adverse clinical consequence should be expected from this change of surgical strategy, justified by the conditions detected during surgery.No reason to suspect a malfunctioning device.Visual inspection performed by r&d spine manager: during visual inspection, the pedicle screw (ref.(b)(4), lot 2126415) has been analyzed and is conform to specification.The myspine planning has been reviewed and no anomalies were found.The reported event may be related to many factors, including the need to place the screw very close to the cortical, increasing the likelihood of bone fracture.No definitive root cause can be established.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15664975
• MDR Text Key: 302338482
• Report Number: 3005180920-2022-00805
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857591
• UDI-Public: 07630030857591
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.52.324
• Device Catalogue Number: 03.52.324
• Device Lot Number: 2126415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2021
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian