MAUDE Adverse Event Report: SURGENTEC, LLC TILINK-P SCREW 12MM X 25MM; SMOOTH OR THERADED METALLIC BONE FIXATION FASTENER

Catalog Number	SI-SGT-25
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/11/2025
Type of Reportable Event	Death
Event or Problem Description
The case was on (b)(6) 2025 at 7:30 am.Rep stated that it was a routine case.Rep also stated there was minor bleeding that occurred during the surgery, and they had it under control in less than a minute.Rep also stated that no surgentec instruments were faulty or had any issues prior to or during the case.The patient did not stay under anesthesia longer than originally anticipated.The rep then stated that the patient stood up 6.5 hours post-op and experienced a vascular issue.The patient then ultimately passed away.

• Brand Name: TILINK-P SCREW 12MM X 25MM
• Common Device Name: SMOOTH OR THERADED METALLIC BONE FIXATION FASTENER
• Manufacturer (Section D): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer (Section G): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer Contact: guilherme pires ; 911 clint moore rd; boca raton 33487 ; 5619907882
• MDR Report Key: 22019293
• Report Number: 3012495575-2025-00003
• Device Sequence Number: 18348836
• Product Code: OUR
• UDI-Device Identifier: 00810131880842
• UDI-Public: 00810131880842
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K242141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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 Catalogue Number: SI-SGT-25
• Device Lot Number: S005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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: Death
• Patient Sex: Unknown