MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED COMPRESSION HEADLESS SCREW; 6.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 50MM

Model Number	04.334.750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following adverse event was discovered as part of a retrospective clinical trial: patient had a ct scan performed on (b)(6) 2023 confirmed non-union.Pt was rx'd a bone stimulator to begin using daily.He had another ct scan done on (b)(6) 2023 with continued non-union.He continued using bone stimulator and brace until he was cleared for surgical correction on (b)(6) 2024 (18 months post op).The event was continuous, had severe symptoms, was not serious, had a probable relationship to the study device, and hospitalization was required.The subject recovered without sequelae.
Additional Manufacturer Narrative
The event was identified as part of a retrospective clinical study.Clinician determined the event has a possible relationship with the study device, however no device malfunction or defect has been reported.There are no identified trends associated with the reported event.The root cause cannot be established.

• Brand Name: CANNULATED COMPRESSION HEADLESS SCREW
• Common Device Name: 6.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 50MM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017
• MDR Report Key: 21472733
• Report Number: 3012966183-2025-00005
• Device Sequence Number: 3491826
• Product Code: HWC
• UDI-Device Identifier: 00819917025835
• UDI-Public: 00819917025835
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/26/2025

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 Model Number: 04.334.750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/26/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 73 KG