MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 8X50MM; SPINE PEDICLE SCREW

Model Number	03.50.056
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to screw loosening.2 screws were exchanged with 10x50 mm.Primary surgery date unknown.The patient's bone was slightly osteoporotic according to the surgeon.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 8X50MM
• 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: 13803783
• Report Number: 3005180920-2022-00178
• Device Sequence Number: 4104874
• Product Code: NKB
• UDI-Device Identifier: 07630030834431
• UDI-Public: 07630030834431
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 03.50.056
• Device Catalogue Number: 03.50.056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/18/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White