MAUDE Adverse Event Report: TYBER MEDICAL TPLIF INTERBODY SYSTEM; PLIF TYPEEK COATED 24MM X 10MM X 10MM X 4°

Model Number	M2-P2410410-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	12/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event was evaluated and investigated with the information provided from the retrospective clinical study and attending surgeon.No lot information was provided; therefore, a dhr review could not be performed.A device evaluation was not able to be performed as the impacted device was not returned for assessment.The root cause cannot be established with the information that is currently available.
Event or Problem Description
Adverse event identified as part of a retrospective clinical study: at 12.5 months post operative, the subject developed right sided weakness and loss of sensation leading to additional surgery (right l4/l5, l5/s1 foraminotomy).The event was continuous, severe, serious, and unanticipated.The site stated that the event could have had a possible relationship to the subject device, but the patient recovered without sequelae.More notes on the event state the subject had right sided weakness that progressed to the inability to lift the right foot without assistance.Patient was initially referred to pain management for right sided l4/l5, l5/s1 transforaminal injections, but the patient saw no improvement in symptoms and was then treated surgically via right l4/l5, l5/s1 foraminotomy.Symptoms improved following this procedure, no further mention of symptoms prompted intervention.

• Brand Name: TPLIF INTERBODY SYSTEM
• Common Device Name: PLIF TYPEEK COATED 24MM X 10MM X 10MM X 4°
• 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: 24005230
• Report Number: 3012966183-2026-00002
• Device Sequence Number: 21136041
• Product Code: MAX
• UDI-Device Identifier: M695M2P2410410S0
• UDI-Public: M695M2P2410410S0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: M2-P2410410-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/08/2026
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 59 KG