MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X9X28 MM; INTERBODY SPACERS

Model Number	108812009
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a tlif (l4-5) for spondylolisthesis on january 5, 2023.The surgery was completed successfully with no surgical delay.After surgery, it was confirmed that the t-pal was coming loose, and the 4 screws were loose.On unknown date, a revision surgery was performed.In the revision surgery, the t-pal was removed, and the 4 screws were replaced.The revision surgery was completed successfully with no surgical delay.The cause of loosening is unknown.The surgeon's comment on this event is none.The patient's bone quality was fragile.No further information is available.This complaint involves five (5) devices.
Additional Manufacturer Narrative
Root cause cannot be determined with the information provided.The complaint device was not returned and lot identifying information was not provided, so neither a device evaluation nor a dhr review for lot related non-conformances could be performed.However, physician feedback indicates that the loosing of the cage was potentially caused by the loosing of the screws which were not tm products and fragile patient anatomy.

• Brand Name: T-PAL PROTI 10X9X28 MM
• Common Device Name: INTERBODY SPACERS
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: jeff zoleta ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 17442815
• Report Number: 3012966183-2023-00014
• Device Sequence Number: 14077009
• Product Code: MAX
• UDI-Device Identifier: 00819917021646
• UDI-Public: 00819917021646
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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: 108812009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female