MAUDE Adverse Event Report: TYBER MEDICAL ACIS® PROTI 360°¿; INTERBODY CAGE

Model Number	108843306
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunction has been observed at this time and the device does not contain cobalt.A causal relation between the device and observed patient impact cannot be definitively established at this time.No further details have been provided to date.Additional information, including x-rays and treatment plans, has been requested.No reported signs of patient harm outside of the bone marrow edema and impending revision surgery.A third party surgeon has been consulted for evaluation.No patient details have been made available at this time.The root cause cannot be determined with the current information.
Event or Problem Description
Bone marrow edema after acis proti cage implantation; questionable allergic reaction (cobalt - not confirmed).Patient will be re-operated on in the nearer future, but no date provided, to remove both cages and replace with autograft, iliac crest, and anterior cervical plate.

• Brand Name: ACIS® PROTI 360°¿
• Common Device Name: INTERBODY CAGE
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017
• MDR Report Key: 22755906
• Report Number: 3012966183-2025-00017
• Device Sequence Number: 8651910
• Product Code: ODP
• UDI-Device Identifier: 00819917020496
• UDI-Public: 00819917020496
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: Health Professional
• Device Model Number: 108843306
• Device Lot Number: 271134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown