MAUDE Adverse Event Report: TYBER MEDICAL T-PAL PROTI 10X7X28 MM; INTERBODY SPACERS

Model Number	108812007
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a posterior lumbar interbody fusion (l5/s) for spinal canal stenosis on (b)(6) 2023.In the surgery, for l5/s fusion, the l5/s intervertebral space was narrow, only about 7 mm or less, and the surgeon extended it to 9 mm.The sharp spoon was also a little deeper during the intervertebral dissection.The surgeon inserted the cage (108812007) 7 mm, but the cage fell out anteriorly during insertion.He tried to put it back once but couldn't.Intraoperative imaging confirmed the anterior median dropout.He decided that it would be impossible to remove the cage from the rear.L5/s was fixed with pps.The surgery was completed successfully within 30 minutes surgical delay.After the surgery, the surgeon commented that he might overextended the vertebrae a bit.The revision surgery is scheduled on (b)(6) 2023.No further information is available.
Additional Manufacturer Narrative
The investigation found no issues with manufacturing after reviewing the device's lot manufacturing information.It was also noted the device was inspected for both titanium coating and tantalum pin placement--both met specification.The root cause identified for this complaint is user error.This is supported by the comments of the surgeon (overextending the vertebrae) and that trialing and implant insertion under fluoro is recommended.It is recommended the surgeon confirm trial and implant location using fluoro during intra-operative use to prevent over-extending into the anterior space.
Event or Problem Description
It was reported that this was a posterior lumbar interbody fusion (l5/s) for spinal canal stenosis on (b)(6) 2023.In the surgery, for l5/s fusion, the l5/s intervertebral space was narrow, only about 7 mm or less, and the surgeon extended it to 9 mm.The sharp spoon was also a little deeper during the intervertebral dissection.The surgeon inserted the cage (108812007) 7 mm, but the cage fell out anteriorly during insertion.He tried to put it back once but couldn't.Intraoperative imaging confirmed the anterior median dropout.He decided that it would be impossible to remove the cage from the rear.L5/s was fixed with pps.The surgery was completed successfully within 30 minutes surgical delay.After the surgery, the surgeon commented that he might overextended the vertebrae a bit.The revision surgery is scheduled on (b)(6) 2023.No further information is available.

• Brand Name: T-PAL PROTI 10X7X28 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18160985
• Report Number: 3012966183-2023-00025
• Device Sequence Number: 15272619
• Product Code: MAX
• UDI-Device Identifier: 00819917021622
• UDI-Public: 00819917021622
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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: 11/12/2025
• Device Model Number: 108812007
• Device Lot Number: 20272AX01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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 Age: 61 YR
• Patient Sex: Female