MAUDE Adverse Event Report: TYBER MEDICAL A.L.P.S. MVX; ANATOMIC LAT FIB PLATE 4H RT

Model Number	770708042
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The bone fragment broke on the interfrag screw and the surgeon felt that one point of fixation proximally was not adequate for this to heal so we opted to revise the plate and put on a different plate.
Additional Manufacturer Narrative
The complaint was investigated without the affected device or lot information.A device history record review was not able to be performed, as no lot information was provided.A device evaluation was not able to be performed as the affected device was not available for return after explantation.An interview was held with the representative present in the surgery that reiterated the surgeon decided to revise the plate after the bone fragment broke as one point of fixation proximally was not adequate for the fracture to heal.At the time of this report, the root cause cannot be determined with the current information available.

• Brand Name: A.L.P.S. MVX
• Common Device Name: ANATOMIC LAT FIB PLATE 4H RT
• 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: 21049117
• Report Number: 3012966183-2024-00026
• Device Sequence Number: 3278993
• Product Code: HRS
• UDI-Device Identifier: 00196449015535
• UDI-Public: 00196449015535
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K232652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2024

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: 770708042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/31/2024
• 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: 68 YR
• Patient Sex: Male