MAUDE Adverse Event Report: ALLUMIN8 INC ALLUMIN8 INTEGR8 POROUS PEDICLE SCREW SYSTEM

Catalog Number	A8-55-0040
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that the 5.5x40mm screws and the 5.5x50mm screws were mis-assembled during the manufacturing of the assembly.Since the screws were mis-assembled with the wrong length, the packaging labeling was not representative of the actual screw length.
Event or Problem Description
After inserting the screws, the surgeon noted that the screw lengths were too long, so he explanted two of the screws and replaced them with other screws.

• Brand Name: ALLUMIN8 INTEGR8 POROUS PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): ALLUMIN8 INC; 3158 west lakefront court; springfield MO 65810
• Manufacturer (Section G): ALLUMIN8 INC; 3158 west lakefront court; springfield MO 65810
• Manufacturer Contact: todd wallenstein ; 3158 west lakefront court; springfield, MO 65810 ; 4176892424
• MDR Report Key: 25315730
• Report Number: 3043234953-2026-00002
• Device Sequence Number: 9893732
• Product Code: NKB
• UDI-Device Identifier: 10850062071039
• UDI-Public: 10850062071039
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K242827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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 Catalogue Number: A8-55-0040
• Device Lot Number: 0167-2508664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 12/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: A8-55-0040, LOT 0167-2508664.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG