MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X10X28 MM; INTERBODY SPACERS

Model Number	108812010
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was an unknown surgery performed on (b)(6) 2023.After surgery, the proti t-pal was found to be slightly backed out.On (b)(6) 2023, a removal surgery was performed and the proti t-pal was removed.The affected area was re-fixed with a cage that was 1 mm higher than the one previously used.It was also found that the screw at s1 was loose.The removal surgery was completed successfully with no surgical delay.No further information is available.This complaint involves one (1) device.
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.A historical data review was conducted.In 36 months, there have been a total of 10 complaints of which 2 were for a similar issue.There have been no capas or non-conformances related to the complaint event.As the complaint event was described, a successful refixation with a cage that is 1mm higher than the originally implanted device indicates that the implant size selected by the surgeon during the initial placement was too small.

• Brand Name: T-PAL PROTI 10X10X28 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: 17216781
• Report Number: 3012966183-2023-00010
• Device Sequence Number: 20386988
• Product Code: MAX
• UDI-Device Identifier: 00819917021653
• UDI-Public: 00819917021653
• 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
• Device Explanted 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): 06/28/2023

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: 108812010
• Device Catalogue Number: 108812010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown