MAUDE Adverse Event Report: ULRICH MEDICAL USA CORTIUM; THORACIC SCREW, DIA 4.5 MM, LENGTH 25 HIGH ANGULATION HEAD

Model Number	UU071-20-4525
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon put on a connector that was lateral and short.The surgeon then noticed the t2 screw was a little lateral and not aligned properly.He proceeded and put the set screw into to the connector and tightened the first set screw of the connector to the rod and had no issues.He then went to tighten the set screw to the tulip and noticed it was not going in right.Upon final tightening he heard a pop, and the tulip splayed and one side the set screw popped out of a thread.They backed the screw out again, then removed the pedicle screw and switched it out with a new one without realigning.The surgeon loosened the lateral connector to relieve the forces on the one side of the second pedicle screw which replaced the first screw, and it splayed again.They then removed the second screw that had also splayed due to the misalignment and replaced it with a third screw, but this time adjusted it to line up better with the rod and connector, then it locked down.The screw did not splay this time as the alignment was correct.The patient was not affected, and the case went fine otherwise.

• Brand Name: CORTIUM
• Common Device Name: THORACIC SCREW, DIA 4.5 MM, LENGTH 25 HIGH ANGULATION HEAD
• Manufacturer (Section D): ULRICH MEDICAL USA; 3700 east plano parkway; suite 200; plano TX 75074
• Manufacturer (Section G): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, bw 89081 ; GM 89081
• Manufacturer Contact: louis milos ; 3700 east plano parkway; suite 200; plano, TX 75074 ; 4692380832
• MDR Report Key: 20912746
• Report Number: 3005823819-2024-00023
• Device Sequence Number: 7778759
• Product Code: NKG
• UDI-Device Identifier: 00814386026819
• UDI-Public: 00814386026819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 12/11/2024

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: UU071-20-4525
• Device Catalogue Number: UU071-20-4525
• Device Lot Number: U040681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown