MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

Catalog Number	03.52.323
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 november 2019.Lot 1921243: 200 items manufactured and released on 05-jul-2019.Expiration date: 2024-06-19.No anomalies found related to the problem.To date, 83 items of the same lot have been already sold without any other similar reported event.Other device involved in the event: pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm lot.1922914 (k141988).Batch review performed on 07 november 2019.Lot 1922914: 200 items manufactured and released on 23-sep-2019.Expiration date: 2024-08-27.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The enh.Poly-axial pedicle screw - cannulated 6x40mm was inserted, but the screw loosening was confirmed after inserting the screw completely into the bone.One possible reason was the pedicle screw thread was not fully designed near the pedicle screw tulip, so the thread could not be fixed at the cortical bone completely and it was not able to obtain the fixing force.Pedicle screw was replaced with the backup pedicle screw.Due to this event the surgery was prolonged about 20 minutes.Patient bone quality was not good.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the pedicle screw, ref 03.52.323, lot 1921243, is according to the specification.The potential root cause of the event is the poor quality of the bone of the patient.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
• Common Device Name: ENH. POLY-AXIAL PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9374815
• Report Number: 3005180920-2019-00988
• Device Sequence Number: 16680953
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 06/19/2024
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1921243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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