MAUDE Adverse Event Report: Stryker GmbH Pangea Humerus Plating Proximal Humerus Posterior Plate, R 3.5mm, 86mm/3; Plate, fixation, bone

Catalog Number	540083S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient underwent open reduction and internal fixation for a humeral fracture on (b)(6) 2025.On (b)(6) 2026, refracture associated with loss of fixation of the humeral plate was identified.Revision surgery was performed on (b)(6) 2026, and the fixation was converted to an intramedullary nail.Two x-ray images regarding reported issue were provided from the facility.".
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: Pangea Humerus Plating Proximal Humerus Posterior Plate, R 3.5mm, 86mm/3
• Common Device Name: Plate, fixation, bone
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker Trauma GmbH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50431520
• Report Number: 0008031020-2026-01344
• Device Sequence Number: 18746408
• Product Code: HRS
• UDI-Device Identifier: 07613327609028
• UDI-Public: 07613327609028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190402
• 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): 08/25/2026

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: 540083S
• Device Lot Number: AR8766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/25/2026
• 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