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

Model Number 108812007

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/28/2020

Event Type  malfunction  

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 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
• Type of Device: INTERBODY SPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): OERLIKON AM MEDICAL; 10 constitution blvd s; shelton CT 06484
• Manufacturer Contact: mark schenk ; 83 s commerce way; suite 310; bethlehem, PA 18017 ; 6108940645
• MDR Report Key: 11132482
• MDR Text Key: 241057651
• Report Number: 3012966183-2021-00001
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00819917021622
• UDI-Public: 00819917021622
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention