MAUDE Adverse Event Report: Stryker GmbH AxSOS 3 Proximal Lateral Humerus Plate For Right Humerus 4 Hole / L99mm; Plate, Fixation, Bone

Catalog Number	627234S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), the surgery for a proximal humeral fracture was performed using an axsos ph plate; however, one cortical screw and one locking screw in the distal region have become loose and are due to be removed on (b)(6).X-rays also suggest that the locking screw in the proximal region is becoming loose.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.

• Brand Name: AxSOS 3 Proximal Lateral Humerus Plate For Right Humerus 4 Hole / L99mm
• 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: 50085785
• Report Number: 0008031020-2026-00924
• Device Sequence Number: 18642486
• Product Code: HRS
• UDI-Device Identifier: 07613327091281
• UDI-Public: 07613327091281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222381
• 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): 07/30/2026

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: 627234S
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/30/2026
• 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: Unknown