MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT; SPINE POLYAXIAL SCREW

Model Number	03.75.002
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the primary spine surgery, during final implantation, when the surgeon was torquing out the rods, 3 of the set screws were not able to be torqued down.The surgeon had to remove the screws and implant new screws.There was a 30-minute delay and the surgery was completed successfully.A consignment set was utilized.
Additional Manufacturer Narrative
No document review could be performed since the lot numbers of the items involved are unknown.

• Brand Name: MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT
• Common Device Name: SPINE POLYAXIAL 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: 14485015
• Report Number: 3005180920-2022-00384
• Device Sequence Number: 19986865
• Product Code: NKG
• UDI-Device Identifier: 07630030863165
• UDI-Public: 07630030863165
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.75.002
• Device Catalogue Number: 03.75.002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/24/2022
• 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: Other
• Patient Sex: Unknown