MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCHED (DOUBLE PACKAGING)

Catalog Number 03.30.132

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 19 november 2018: lot 1820441: (b)(4) items manufactured and released on 21-jun-2018.Expiration date: 2023-05-14.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.

Event Description

From the final per-op x-rays the surgeon detected that the plate was proud by 1mm from the anterior portion of the vertebral body.He proceeded to use the fixed straight screw driver to bring the plate down and by overnighting the screw, the head sheared off.There were no fragments, it was a clean break.The screw shank was left in place, buried/countersunk in the cage/bone.The broken screw head was removed.No deformation or breakage of the instruments occurred.There were a five minutes of delay in the case.The surgery was completed successfully.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCHED (DOUBLE PACKAGING)
• Type of Device: 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: 8084558
• MDR Text Key: 129301530
• Report Number: 3005180920-2018-00916
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07630030875427
• UDI-Public: 07630030875427
• Combination Product (y/n): N
• PMA/PMN Number: K160605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Catalogue Number: 03.30.132
• Device Lot Number: 1820441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2018
• 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): Other