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

Catalog Number	A8-55-0050
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
During a post-op review of the x-ray it was noticed that the allumin8 screws looked shorter than the other company's screws which were 50mm in length.The a8 box that was opened said they are 5.5 x 50 mm 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: 25315727
• Report Number: 3043234953-2026-00001
• Device Sequence Number: 15926236
• Product Code: NKB
• UDI-Device Identifier: 10850062071053
• UDI-Public: 10850062071053
• 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
• 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: A8-55-0050
• Device Lot Number: LOT0168-2508665
• Was Device Available for Evaluation?: No
• 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
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A8-00-CAP, LOT 2508661, QTY 4.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 68 KG