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

Model Number 03.50.032

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/19/2022

Event Type  Injury  

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3 months after bi-level lumbar stabilization surgery, an infection occurs and requires revision.All implants are withdrawn and substituted.There is no reason to suspect that the infection was caused by the implanted devices.The involved devices and their lots are not available.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 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
• Type of Device: 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
• MDR Text Key: 286639348
• Report Number: 3005180920-2022-00120
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 07630030834301
• UDI-Public: 07630030834301
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K121115
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.50.032
• Device Catalogue Number: 03.50.032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White