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

Model Number	108812009
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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 will not be returned, and therefore cannot be evaluated.A review of the lot was conducted and found one non-conformance related to this unrelated to this specific complaint type.The parts were scrapped and 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/continous improvement process.No further action is required at this time.Complaint number (b)(4).
Event or Problem Description
For the case on (b)(6) 2021, a 9mm proti cage 108812009 (206128 lot) needed to be condemned as the cage disengaged from the applicator.Parts of the applicator are listed as follows, applicator inner shaft (03.812.003) + applicator outer shaft (03.812.001)+ applicator knob (03.812.004).The surgeon inserted applicator with 9mm pro-ti cage.A standard procedure was followed, the cage was first inserted in a locking state, the turned the know to open for turning the cage.As the position of the cage was slightly anterior.So surgeon decided to use a slide hammer to move the cage in posterior direction.The slide hammer was operated in a gentle and controlled force.Yet, suddenly, the cage detached from the applicator.Removal tool was attempt to grab the implant, yet, there was not enough space to insert the removal tool.The disengaged implant was removed from anterior approach through another incision.Synfix evolution was used to fuse l5-s1.Surgeon would like us to investigate why the cage disengaged from the applicator.

• 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: 11423326
• Report Number: 3012966183-2021-00006
• Device Sequence Number: 11781180
• Product Code: MAX
• UDI-Device Identifier: 00819917021646
• UDI-Public: 00819917021646
• Combination Product (Y/N): N
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 03/20/2025
• Device Model Number: 108812009
• Device Catalogue Number: 108812009
• Device Lot Number: 206128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/05/2021
• 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