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

Catalog Number	03.30.132
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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)
• Common Device Name: SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8084558
• Report Number: 3005180920-2018-00916
• Device Sequence Number: 19197165
• Product Code: OVD
• UDI-Device Identifier: 07630030875427
• UDI-Public: 07630030875427
• Combination Product (Y/N): N
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2023
• Device Catalogue Number: 03.30.132
• Device Lot Number: 1820441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other