MAUDE Adverse Event Report: TYBER MEDICAL 6.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 50MM 2; TRAUMA SCREW

Model Number	04.333.750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561); Radiolucent Lines (4848)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted for an event that was identified as part of a historical data review comparing clinical trial adverse events with the vigilance system.The complaint was investigated without specific device lot information or the affected device.As part of the investigation, a second opinion was obtained from a different clinician to evaluate radiographs.The second opinion concluded that the event is a nonunion without failure of instrumentation, and that while it may heal with the bone growth stimulator, a revision surgery may be required.The patient was lost to follow-up as symptoms persisted.A historical data analysis revealed no trends or capas associated related to the nature of this complaint.The cause cannot be determined with the current information.
Event or Problem Description
Details from clinical study: at 6 months post-operative, it was noted that "screw loose; radiolucency".The subject did not have the ability to walk/perform activities of daily living without pain.The subject was instructed to continue using the bone growth stimulator for the next 6-weeks and return for follow-up.Subject was lost to follow-up after the 6-month post-operative visit.Unknown if subject returned to normal activity or received additional treatment regarding the lucency.At the final clinic visit the subject was advised to restrict weight bearing and continue to use boot and crutches; subject cancelled follow-up visits.Subject was lost to follow-up after the 6-month postoperative visit.Unknown if subject returned to normal activity or received additional treatment.

• Brand Name: 6.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 50MM 2
• Common Device Name: TRAUMA SCREW
• 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 ; 8667610933
• MDR Report Key: 20493245
• Report Number: 3012966183-2024-00017
• Device Sequence Number: 4174405
• Product Code: HWC
• UDI-Device Identifier: 00819917025644
• UDI-Public: 00819917025644
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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
• Device Model Number: 04.333.750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 10/21/2024
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 110 KG