MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTI 5 DG, 9X9X27 MM; INTERBODY SPACERS

Model Number	188827409
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a transforaminal lumbar interbody fusion (l5/s1) for lumbar spinal canal stenosis on (b)(6) 2023.The primary surgery was performed on (b)(6) 2023 with concorde.After the surgery, the backed out of concorde in question was confirmed on an unknown date.On (b)(6) 2023, the second surgery was performed to remove the set screw (expedium verse) and the rod and to hummer the concorde in 5 mm.The surgeon applied compression between the screws.No further information is available.

• Brand Name: CONCORDE PROTI 5 DG, 9X9X27 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: 18163452
• Report Number: 3012966183-2023-00026
• Device Sequence Number: 20458997
• Product Code: MAX
• UDI-Device Identifier: 00819917021295
• UDI-Public: 00819917021295
• 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
• Device Explanted 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
• 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: 07/09/2024
• Device Model Number: 188827409
• Device Lot Number: 203401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/17/2023
• 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