MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X50MM; PEDICLE SCREW IMPLANT

Catalog Number	03.52.325
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 october 2018.Lot 1621164: (b)(4) items manufactured and released on 02 february 2017.Expiration date: 2022-01-01.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.Additional implant involved and revised: lot 164296: (b)(4) items manufactured and released on 25 july 2016.Expiration date: 2021-07-07.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
Patient came in complaining of pain 2 months after primary.The surgeon thought the screws may have been fractured.Upon opening the patient, the surgeon determined that the screws were not fractured.The surgeon was displeased with screws placement.The surgeon revised 2 screws.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X50MM
• Common Device Name: PEDICLE SCREW IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8023978
• Report Number: 3005180920-2018-00852
• Device Sequence Number: 1756149
• Product Code: NKB
• UDI-Device Identifier: 07630030857607
• UDI-Public: 07630030857607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 03.52.325
• Device Lot Number: 1621164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/31/2018
• 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: Required Intervention