MAUDE Adverse Event Report: TYBER MEDICAL CONCORDE PROTIP 9 X7 X 23MM; INTERBODY SPACERS

Model Number	188823107
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Arthritis (1723)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was a tlif for the spinal stenosis on (b)(6) 2022.Although the cage has been inserted in proper position, the cage backed out backwards after the primary surgery.Therefore, a revision surgery will be performed on (b)(6) 2023.No further information is available.This complaint involves one.
Additional Manufacturer Narrative
The device history record was reviewed.(b)(4) devices were manufactured january 20th of 2022.The expiration date is january 20th of 2027.The devices were made to specifications.There are no-nonconformances related to this issue.Lot met acceptance criteria.There are no capas associated with this lot.There are no other complaints related to this lot.

• Brand Name: CONCORDE PROTIP 9 X7 X 23MM
• 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: jeff zoleta ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 16215490
• Report Number: 3012966183-2022-00039
• Device Sequence Number: 6033625
• Product Code: MAX
• UDI-Device Identifier: 00819917020748
• UDI-Public: 00819917020748
• 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: 2022
• 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): 01/20/2023

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 Model Number: 188823107
• Device Catalogue Number: 188823107
• Device Lot Number: 232805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/20/2023
• 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