MAUDE Adverse Event Report: Avalign German Specialty Instruments Millennium; Debakey Jaw Grasper

Model Number	72-5223622B10
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction

• Brand Name: Millennium
• Common Device Name: Debakey Jaw Grasper
• Manufacturer (Section D): Avalign German Specialty Instruments; 626 cooper court; schaumburg IL 60173
• Manufacturer (Section G): Avalign German Specialty Instruments; 626 cooper court; schaumburg IL 60173
• Manufacturer Contact: seth rindner ; 626 cooper court; schaumburg, IL 60173 ; +1(847)908-0292
• MDR Report Key: 50572194
• Report Number: 1421101-2026-00003
• Device Sequence Number: 10293536
• Product Code: GEI
• UDI-Device Identifier: 00190776416034
• UDI-Public: 00190776416034
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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
• Operator of Device: Health Professional
• Device Model Number: 72-5223622B10
• Device Catalogue Number: 72-5223622B10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male