MAUDE Adverse Event Report: Stryker GmbH VariAx Elbow Distal Lateral Humerus Plate For Right Humerus 3 Hole /; Plate, Fixation, Bone

Catalog Number	629223S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: VariAx Elbow Distal Lateral Humerus Plate For Right Humerus 3 Hole /
• Common Device Name: Plate, Fixation, Bone
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50809697
• Report Number: 0008031020-2026-01603
• Device Sequence Number: 12910762
• Product Code: HRS
• UDI-Device Identifier: 07613327082388
• UDI-Public: 07613327082388
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: Lay User/Patient
• Device Catalogue Number: 629223S
• Device Lot Number: AU6852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Patient Sex: Female