MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X8X28 MM; INTERBODY SPACERS

Model Number	108812008
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned; therefore, a device evaluation was not performed as it was discarded by the end user.There was no photographic evidence provided.There was no further information provided by the customer to confirm the complaint event and any correlation to the device.There was no lot information provided by the complainant; therefore, a device history record could not be performed.A part number history data review was performed.Within 36 months there have been three complaints for this part number.There was no other instance of the complaint event reported.There have been a total of 23 internal non-conformances during manufacturing in-process inspection where the majority of non-conformant pieces were dispositioned to be scrapped.There have been no capas related to this part number.The complaint rate for this part number is 0.1%.Without further information to confirm the complaint event and correlation to the device or the device for further evaluation, the complaint event root cause is indeterminate.
Event or Problem Description
It was reported that this was a tlif (l4 to l5) for the spondylolisthesis on (b)(6) 2022.The surgery was completed successfully without any surgical delay.After the surgery, the patient was infected.The cage was removed.No further information is available.This complaint involves one (1) device.Implant date (b)(6) 2022.

• Brand Name: T-PAL PROTI 10X8X28 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: 16530776
• Report Number: 3012966183-2023-00004
• Device Sequence Number: 20186313
• Product Code: MAX
• UDI-Device Identifier: 00819917021639
• UDI-Public: 00819917021639
• 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: 2022
• 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): 03/13/2023

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: 108812008
• Device Catalogue Number: 108812008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/13/2023
• 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