MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 7X50; SPINE PEDICLE SCREW

Model Number	03.50.032
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: 3 months after bi-level lumbar stabilization surgery, an infection occurs and requires revision.All implants are withdrawn and substituted.There is no reason to suspect that the infection was caused by the implanted devices.The involved devices and their lots are not available.
Event or Problem Description
At about 4 months after the primary, revision surgery performed due to implant-associated early lumbal infection (staphylococcus epidermis, cutibacterium acnes).Screws and rods were revised (l4-s1).The cage was replaced with a competitor's cage.

• Brand Name: PEDICLE SCREW 7X50
• Common Device Name: SPINE PEDICLE SCREW
• 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: 13542265
• Report Number: 3005180920-2022-00120
• Device Sequence Number: 11837034
• Product Code: KWP
• UDI-Device Identifier: 07630030834301
• UDI-Public: 07630030834301
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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 Model Number: 03.50.032
• Device Catalogue Number: 03.50.032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White