MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX¿; ANTLATERAL TIB PLT 10H LT WIDE

Model Number	770714101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was investigated through historical data analysis, an interview with the associated sales rep, and a radiographical review conducted via a 3rd party surgeon.Radiographs and other images were analyzed by a 3rd party surgoen and concluded that the plate was designed for load sharing and not for supporting segmental defects on its own.The actual device was not returned for testing; therefore a device evaluation was unable to be performed.No lot information has been made available; therefore a device history record returned inconclusive results.At the time of the investigation, there were no trends or capas related to the nature of this complaint.With the current information, a root cause of the plate fracture can be traced to component failure, as the plate was being used to support segmental defects.If further information becomes available, a supplemental report shall be submitted.
Event or Problem Description
Sales rep stated that the initial case was completed in end june/early july.It was a 23 yr old female approx 180 lbs.The mechanism of injury was a gunshot wound to the ankle.She stated there was ankle was a mess and the surgeon said he expected healing may be an issue.The facture was a non-union which is why the plate eventually broke.The surgeon cut out the bad bone, filled it with bone cement and placed another al tibia plate in the revision surgery.

• Brand Name: A.L.P.S. MVX¿
• Common Device Name: ANTLATERAL TIB PLT 10H LT WIDE
• 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: 21777916
• Report Number: 3012966183-2025-00008
• Device Sequence Number: 12969048
• Product Code: HRS
• UDI-Device Identifier: 00196449015894
• UDI-Public: 00196449015894
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K232652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/04/2025

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: 770714101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/04/2025
• 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: Required Intervention; Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 82 KG