MAUDE Adverse Event Report: TYBER MEDICAL TPAL PRO TI 10X 8X 28MM; INTERBODY SPACER

Model Number	108812088
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 the patient underwent a primary tlif (l4-5) procedure without surgical delay.On an unknown date it was found that the cage had backed out.On (b)(6) the patient is scheduled to undergo a revision procedure.The surgeon wondered if the cage might have triggered the event.No further information is available.This complaint involves one (1) device.
Additional Manufacturer Narrative
The device history record was reviewed and there were no issues found.The device was not returned so n evaluation was not performed.There were no non-conformances or capas associated with this lot and the lot met acceptance criteria.Expulsion from a disc space can lead to serious injury, however, expulsion is often due to external forces or poor cage placement, not cage design.However, the investigation was non-conclusive as radiographic imaging and the device were not returned.The root cause could not be determined.

• Brand Name: TPAL PRO TI 10X 8X 28MM
• Common Device Name: INTERBODY SPACER
• 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 14397556
• Report Number: 3012966183-2022-00017
• Device Sequence Number: 5500036
• 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
• Device Explanted 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): 05/13/2022

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: 108812088
• Device Catalogue Number: 108812008
• Device Lot Number: 205910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/13/2022
• 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