MAUDE Adverse Event Report: Stryker Medical-Kalamazoo 6257 XPEDITION HIGH CONFIG; BED, PATIENT ROTATION, POWERED

Catalog Number	625705550002
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between (b)(6)- (b)(6) 2026.This report summarizes 2 malfunction events(s), where it was reported the devices experienced accessible sharp metal edges.No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.Evaluation results findings: 2 devices: chassis/frame / fracture problem.There was no remedial action taken.This device is not labeled for single use.

• Brand Name: 6257 XPEDITION HIGH CONFIG
• Common Device Name: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): Stryker Medical-Kalamazoo; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): Stryker Medical-Kalamazoo; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; +1(269)329-2100
• MDR Report Key: 50044277
• Report Number: 0001831750-2026-99306
• Device Sequence Number: 20134841
• Product Code: IKZ
• UDI-Device Identifier: 07613327581607
• UDI-Public: 07613327581607
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2026

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
• Device Catalogue Number: 625705550002
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown