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

Model Number	108812007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of investigation, there was no capa and no trends associated with this event type.The product is not available for return, and therefore cannot be evaluated.A review of lot 112210 was conducted.There was one nonconformance associated with this manufacturing lot.2 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, the primary mis-tlif procedure l5/s was performed to treat lumbar degenerative spondylolisthesis.The procedure was completed less than 30-minute surgical delay.On (b)(6) 2020, the following events were reported: the cage at l5/s1 had backed out.The screw at s1 right had broken off.The patient underwent a revision procedure which succeeded without further issues.The surgeon commented the following: the cage might have become loose which resulted in the back-out before bone healing.The back-out might have put extra load to the screw.No further information is available.This complaint involves two devices.

• Brand Name: T-PAL PROTI 360
• Common Device Name: INTERBODY SPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 11132482
• Report Number: 3012966183-2021-00001
• Device Sequence Number: 19865006
• Product Code: MAX
• UDI-Device Identifier: 00819917021622
• UDI-Public: 00819917021622
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 10/26/2023
• Device Model Number: 108812007
• Device Catalogue Number: 108812007
• Device Lot Number: 112210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/07/2021
• 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