MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45

Model Number	03.50.031
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 1 month after the primary spine surgery, the revision surgery was performed because the s screw (7x45) loosened, came out from the bone, and bone fusion did not occur.The surgery was completed successfully using a 8x50 screw.
Additional Manufacturer Narrative
No analysis could be performed since lot numbers are unknown and devices are not available for inspection.

• Brand Name: PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16246868
• Report Number: 3005180920-2022-01001
• Device Sequence Number: 15031028
• Product Code: KWP
• UDI-Device Identifier: 07630030834295
• UDI-Public: 07630030834295
• 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: 2020
• 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): 01/26/2023

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: 03.50.031
• Device Catalogue Number: 03.50.031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/26/2023
• 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 Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian