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

Model Number	108812009
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 so a device evaluation was not possible.No non-conformances or capas were found on this lot.Lot was released.There is been only one complaint related to a non-union.Root cause cannot be determined or traced back to the device with the information provided.The complaint device was not returned for an evaluation.However, non-union is a known procedural risk for lumbar spinal fusion that is often caused by patient conditions that are entirely unrelated to device performance.The description provided with the complaint indicates that the screws used for the procedure became loose, which may have been a contributing factor for the non-union.
Event or Problem Description
It was reported that this was a tlif (l5/s1) for spinal stenosis on (b)(6) 2022.After surgery, a revision surgery will be performed in (b)(6) 2023 due to loosening of the screws and non-union between l5/s1.In the revision surgery, the cage will be removed and replaced with a competitor's product.The screws will be removed and replaced with sized up screws.The surgeon commented it was unclear if loosening of the screws occurred because of non-union or if loosening of the screws caused non-union.No further information is available.This complaint involves five (5) devices.

• 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: 17380467
• Report Number: 3012966183-2023-00012
• Device Sequence Number: 17697368
• 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: 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): 07/24/2023

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 Expiration Date: 02/11/2026
• Device Model Number: 108812009
• Device Lot Number: 216541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/24/2023
• 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