MAUDE Adverse Event Report: TYBER MEDICAL T PAL PROTI 10 X 9 X 28MM; INTERBODY SPACER

Model Number	108812009
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A historical data review on the part number revealed a total of4 complaints within a 24 month period related to the complaint event not specific to one lot.The 3 additional complaints found on this part number were not related to the complaint event reported.There are no capas or non-conformances found for this part number.The complaint event was evaluated.It appears that during a tlif procedure on (b)(6) 2021, the tlif cage perforated the patient's anterior longitudinal ligament (all) and advanced anteriorly into the abdominal space.The implant was removed from the abdominal space and was reinserted and implanted.The condition of the cage at time of implantation is unknown.The status of the all is unknown.No information was provided regarding surgical steps prior to the event (i.E.Trialing, disc preparation).The procedure was completely successfully with less-than 30 minute surgical delay.The patient was stable post-op.The root cause is indeterminate as there is not enough information nor the returned device for further study.If additional information is received, complaint record will be reopened and processed accordingly.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 (l5/s1) for lumbar spinal canal stenosis on (b)(6) 2021.The cage was inserted into the intervertebral disk.Then, the cage broke through the anterior longitudinal ligament and moved to the anterior side.The cage was removed and reinserted less than 30- minute surgical delay.No further information is available.This complaint involves one (1) device.

• Brand Name: T PAL PROTI 10 X 9 X 28MM
• Common Device Name: INTERBODY SPACER
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 12519610
• Report Number: 3012966183-2021-00022
• Device Sequence Number: 4231619
• 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: 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): 09/23/2021

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: 03/20/2025
• Device Model Number: 108812009
• Device Catalogue Number: 108812009
• Device Lot Number: 206128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/23/2021
• 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