MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 9X60MM; PEDICLE SCREW FOR SPINE IMPLANT

Catalog Number 03.50.076

Device Problem Expiration Date Error (2528)

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

Event Date 06/17/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 25 july 2019 lot 143178: (b)(4) items manufactured and released on 19-may-2014.Expiration date: 2019-03-31.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

Two pedicle screws expired has been implanted.

• Brand Name: PEDICLE SCREW 9X60MM
• Type of Device: PEDICLE SCREW FOR SPINE IMPLANT
• 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: 8877723
• MDR Text Key: 162116831
• Report Number: 3005180920-2019-00671
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030834608
• UDI-Public: 07630030834608
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132878
• 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
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 03.50.076
• Device Lot Number: 143178
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2014
• 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
• Patient Age: 73 YR