MAUDE Adverse Event Report: TYBER MEDICAL T PAL PRO TI 12 X 8 X 32MM; INTERBODYSPACER SYSTEM

Model Number	108812208
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this investigation there wa no trend or capa identified for this event type.The device history record review did not identify any non-confomrances or deviations.The lot was manufactured per specifications and met acceptance criteria.Complaints of this nature are monitored through tracking and trending.If a trend is detected further investigation shall be conducted through the capa/ continuous improvement process.No further actions are required at this time.Complaint number (b)(4).
Event or Problem Description
It was reported there was an unknown procedure performed on (b)(6) 2021.During the cage deployment, the surgeon did not notice that the holder happened to lean outward.Without noticing that he tapped the cage.Then the cage broke.Because the cage had been deployed deep in the intervertebral lesion, he decided not to extract it.The procedure was completed in less than 30 minutes surgical delay.No further information is available.

• Brand Name: T PAL PRO TI 12 X 8 X 32MM
• Common Device Name: INTERBODYSPACER SYSTEM
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce highway; suite 310; bethlehem 18017
• MDR Report Key: 11977266
• Report Number: 3012966183-2021-00013
• Device Sequence Number: 14510617
• Product Code: MAX
• UDI-Device Identifier: 00819917021745
• UDI-Public: 00819917021745
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: 108812208
• Device Catalogue Number: 108812208
• Device Lot Number: 206146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/10/2021
• 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: Other