MAUDE Adverse Event Report: TYBER MEDICAL LLC T-PAL PROTI 360; INTERBODY SPACER SYSTEM

Model Number	108812210
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the investigation, there was no capa and no trends associated with this event type.The product has not yet been returned for evaluation, and therefore the investigation is still pending.A review of lot 112013 was conducted.There was one nonconformance associated with this manufacturing lot.3 pieces were identified as missing coating, and were scrapped.The lot met release requirements.Complaints of this nature are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.No further action is required at this time.Complaint number (b)(4).
Event or Problem Description
"on (b)(6) 2019 a mis-tlif (minimally invasive surgery - transforaminal lumbar interbody fusion) was performed to treat right intervertebral arthritis in l5/s.On (b)(6) 2020 it was reported that the cage had backed out.On (b)(6) the patient will undergo a revision procedure.The surgeon commented as follows: 1.S/he wondered if excessive load might have put the cage to move backward due to the tip's tapered shape.2.In addition to the product's defectiveness, if any, mismatching of cage size and/or the cage's deployed location might have triggered the event.This complaint involves one (1) device.".
Additional Manufacturer Narrative
Customer has opted not to return the device for product evaluation.However, x-ray images were provided and evaluated.While a root cause cannot be definitively determined based on these images, they do suggest that the implant was undersized and not ideally positioned in the disc space.No capa and no trends have been identified.Complaints of this nature are monitored through tracking and trending.(b)(4).

• Brand Name: T-PAL PROTI 360
• Common Device Name: INTERBODY SPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL LLC; 83 s. commerce way; suite 310; bethlehem, pa
• MDR Report Key: 10084045
• Report Number: 3012966183-2020-00003
• Device Sequence Number: 678537
• Product Code: MAX
• UDI-Device Identifier: 00819917021769
• UDI-Public: 00819917021769
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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 Expiration Date: 07/10/2023
• Device Model Number: 108812210
• Device Catalogue Number: 108812210
• Device Lot Number: 112013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR