MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40

Model Number	03.50.030
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 january 2020.Lot 1820669: (b)(4) items manufactured and released on 30-aug-2018.Expiration date: 2023-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Two equal devices were reported in this complaint.Additional implant involved in the complaint, batch review performed on (b)(6) 2020.Mectalif posterior (ti peek) 03.27.029 posterior interbody fusion device peek/ti 11x22x8 l0° (k133192) lot.1721093.Lot 1721093: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-06.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 or Problem Description
Primary surgery was performed on (b)(6) 2019.Plif surgery was performed at l4-s2ai.Revision surgery was performed at l5 due to the loosening of the pedicle screws and none bone fusion of the cage almost 1 year after the primary.The surgeon replaced with new pedicle screws and cage.Primary and revision surgery performed as open.

• Brand Name: PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40
• Common Device Name: PEDICLE SCREW 7X40
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9659907
• Report Number: 3005180920-2020-00020
• Device Sequence Number: 3475155
• Product Code: KWP
• UDI-Device Identifier: 07630030834288
• UDI-Public: 07630030834288
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 08/19/2023
• Device Model Number: 03.50.030
• Device Catalogue Number: 03.50.030
• Device Lot Number: 1820669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/03/2020
• 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
• Patient Age: 80 YR