MAUDE Adverse Event Report: TYBER MEDICAL T PAL PRO TI 12 X 7 X 32MM; INTERBODY SPACER

Model Number	108812207
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record(dhr) review was not conducted as the lot information was not available.A historical data review was performed for the part number which revealed no non-conformances, capas, or quality events on records for this part number.At the time of this review.As described by the complaint event it appears that during a l4/5/s tlif procedure on (b)(6) 2021, the tlif cage fractured during insertion into the l5/s1 disc space.The complaint noted that the vertebral space was limited and the vertebral segment was not mobile.No information was provided if proper disc space preparation or trailing occurred prior to the fracture, additional information has been requested.Retrieval of the cage was attempted post fracture however, a fragment or fragments remain in the patient.It is unknown if another device was implanted.The procedure was completely with over a 30 minute surgical delay.The root cause is indeterminate.If further information becomes available the complaint will be reopened and evaluated further.Complaints of this nature are monitored through tracking and trending and if a trend is detected, further action will be taken through our capa/continuous improvement process.
Event or Problem Description
T was reported that this was a tlif (l4/5/s) for treating lumbar spinal canal stenosis on (b)(6) 2021.After the surgeon inserted the cage at l5/s1, he was not able to turn the cage due to limited intervertebral space and less intervertebral mobility.So he tapped the cage with a hammer.As images showed some awkward shapes of the cage, it was removed from the patient's body.The cage had broken, and the surgeon tried to remove a fragment(s).However, the fragment(s) has been left in the patient's body.The procedure was delayed over 30 minutes.No further information is available.Concomitant device reported: unknown hammer (part# unknown, lot# unknown, quantity unknown) unknown insertion instrument (part# unknown, lot# unknown, quantity unknown) this complaint involves one (1) device.

• Brand Name: T PAL PRO TI 12 X 7 X 32MM
• Common Device Name: INTERBODY SPACER
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 12547485
• Report Number: 3012966183-2021-00023
• Device Sequence Number: 14283324
• Product Code: MAX
• UDI-Device Identifier: 00819917021738
• UDI-Public: 00819917021738
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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 Model Number: 108812207
• Device Catalogue Number: 108812207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other