MAUDE Adverse Event Report: TYBER MEDICAL T-PAL; INTERBODY SPACERS

Model Number	108812010
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed.The lot was manufactured to specifications and was released.There were no capas or non-conformances associated with this lot.A total of 8 complaints were found when performing a historical data review on the part number.Two complaints are for the same complaint event case.There were no trends identified during this review.There were no relates previous complaints events.The complaint from the customer states that the patient underwent a primary tlif procedure on (b)(6) 2021 for lumbar intervertebral foramen stenosis and lumbar disc hernia at l5/6.Clarification was requested from the customer and not received, but the operative level was assumed to be l5/s1.There were no issues reported with the primary surgery.On (b)(6) 2021 the patient underwent a subsequent procedure for removal of a hematoma.This was reported as part of complaint (b)(4).No further information was available for this procedure.On (b)(6) 2021 the patient underwent a revision procedure to address loose pedicle screws at s1 and a retropulsed intervertebral cage.This was reported as part of complaint (b)(4).An x-ray was provided on (b)(6) 2021 that is assumed to be pre-op and post-op xrays of the revision procedure on (b)(6) 2021.The pre-operative x-rays clearly show the intervertebral cage expulsed from the intervertebral disc space.The cage was successfully replaced and no further information was available.The customer did not provide information regarding disc preparation, trialing, and implantation of the primary implant, nor information regarding the disc preparation, trialing, and implantation of the revision implant.It is unknown if proper surgical technique was followed or if any traumatic event may have occurred that could have contributed to the expulsion of the implant.Not enough information was provided to determine a root cause of the failure.
Event or Problem Description
Subsequent to the hematoma removal procedure reported under (b)(4), the patient underwent a revision procedure on (b)(6) 2021 as follows: 199725740s cfx screws (2 pcs.) deployed at l6 had been loose.These screws were replaced.108812010 cage (1 pc.) had come off.The cage was replaced.The procedure was successfully completed.No further information is available.This (b)(4) is related to (b)(4) as follows: (b)(4): about events in the revision procedure on (b)(6) 2021.(b)(4): about postoperative hematoma on (b)(6) 2021.

• Brand Name: T-PAL
• 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 13151358
• Report Number: 3012966183-2021-00024
• Device Sequence Number: 20167190
• 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: 2021
• Device Explanted Year: 2021
• 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): 12/30/2021

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: 04/01/2025
• Device Model Number: 108812010
• Device Catalogue Number: 108812010
• Device Lot Number: 205912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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 Sex: Male