MAUDE Adverse Event Report: TYBER MEDICAL ACIS PROTI LOR/S 6 MM H; INTERBODY SPACER

Model Number	108843606
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Numbness (2415); Implant Pain (4561); Radiolucent Lines (4848)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted for an event that was identified as part of a historical data review comparing clinical trial adverse events with the vigilance system.The event was investigated without the affected device, specific lot information, or known final outcomes to the patient after they left the study.The device remained implanted; therefore, a device evaluation could not be performed.Upon review of clinical records, a specified device malfunction could not be established, however radiolucency was observed around the implant.Further treatment for pain and the symptoms could not be clarified, as patient was lost to follow-up and did not return to the clinic.A historical data analysis was conducted returning no related complaints, nonconformities, or capas associated with the part number.Due to insufficient information regarding a specific device defect, the root cause cannot be established.
Event or Problem Description
Adverse event from the clinical study who was lost to follow-up.Event details from the site are as follows: at 14-months post-operative, radiographs demonstrated solid fusion with graft incorporation at c3-c4 and c4-c5, however c5-c6 was not fused; imaging demonstrated pseudarthrosis and radiolucency along the interface with the vertebral body.Additionally, imaging details, severe disc space narrowing with severe endplate sclerosis indicative of adjacent level disc disease at the level below fusion.At the 17-month post-operative visit, the subject reported neck and arm pain (arm>neck), the subject detailed that the pain radiates down her left shoulder left thoracic flank, and left triceps.The subject also reported numbness and paresthesia in the hand and fingers.The subject was given a steroid injection in the left shoulder however had no meaningful pain relief.The surgeon reported 50-60% improvement from the surgery.At 25-months post-operative, the radiolucency at c5-c6 was still present, however the subject declined further treatment and the device remains.The subject did not return to the clinic after the 25-month post-operative visit.

• Brand Name: ACIS PROTI LOR/S 6 MM H
• Common Device Name: INTERBODY SPACER
• 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 ; 8667610933
• MDR Report Key: 20568807
• Report Number: 3012966183-2024-00020
• Device Sequence Number: 17948263
• Product Code: MAX
• UDI-Device Identifier: 00819917020656
• UDI-Public: 00819917020656
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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
• Device Model Number: 108843606
• 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: 08/17/2022
• Initial Report FDA Received Date: 10/30/2024
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG