MAUDE Adverse Event Report: TYBER MEDICAL ACIS® PROTI 360°¿; ACIS PROTI LOR/M 8 MM H

Model Number	108843008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Event was identified as part of a retrospective clinical study: 6-months post-operative show subsidence (not measured; only the interspinous distances in the flexion and extension views) into the superior endplate of c7 with the graft, which has progressed to a solid fusion.There is neutral alignment from c2 to t1.There is still 3 mm of motion on flexion and extension views, suggesting that the patient is not fully fused at this point 6 months postoperative.However, the ap view reveals bone graft lateral to the spacer on both sides which does generally appear to be fused, so certainly approaching fusion, but not quite there yet.12.5-months post-operative show a solid fusion now at c6-7 with some subsidence (measurement not captured) of the interbody spacer into the c7 superior endplate and less than 1 mm of motion on flexion and extension views.
Additional Manufacturer Narrative
This mdr is being submitted for an event that was identified as part of a historical data review comparing clinical study adverse event with the vigilance system.The complaint was investigated and evaluated without the associated device, as it remains implanted.Event reported as part of a clinical study.No lot information was provided; therefore, a device history record review was unable to be performed.Clinician did not note any implications of defect or failures related to the implanted device.A historical data review was conducted revealing no current trends or capas related to the nature of this complaint.

• Brand Name: ACIS® PROTI 360°¿
• Common Device Name: ACIS PROTI LOR/M 8 MM H
• 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: 21440461
• Report Number: 3012966183-2025-00004
• Device Sequence Number: 4360973
• Product Code: ODP
• UDI-Device Identifier: 00819917020434
• UDI-Public: 00819917020434
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2025

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: 108843008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 02/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG