MAUDE Adverse Event Report: CAPTIVA SPINE TIRBOLOX TLIF LUMBAR IBFD; LUMBAR INTERBODY FUSION DEVICE

Model Number	PI-0100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A field feedback report was reported to the company that there was an incident during a lumbar tlif procedure using the pivotec inserter and lumbar interbody implant, that may have contributed to a dural tear.During insertion of the implant it was described that the implant/instrument interface had unintentional movement from the fully locked position during impaction and insertion.There was less than 20 minutes surgical delay required to address the dural tear.No additional clincal information was provided, and no further health damage reported in the patient.
Additional Manufacturer Narrative
This mdr report is past the reporting date due to gaining access to esg protal for reporting.If information is provided in the future, a supplemental report will be provided.
Event or Problem Description
A field feedback report was reported to the company that there was an incident during a lumbar tlif procedure using the pivotec inserter and lumbar interbody implant, that may have contributed to a dural tear.During insertion of the implant it was described that the implant/instrument interface had unintentional movement from the fully locked position during impaction and insertion.There was less than 20 minutes surgical delay required to address the dural tear.No additional clinical information was provided, and no further health damage reported in the patient.
Additional Manufacturer Narrative
This mdr report is past the reporting date due to gaining access to esg protal for reporting.If information is provided in the future, a supplemental report will be provided.

• Brand Name: TIRBOLOX TLIF LUMBAR IBFD
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): CAPTIVA SPINE; 967 n. alternate a1a ste 1; jupiter FL 33477
• Manufacturer (Section G): CAPTIVA SPINE; 967 n. alternate a1a; ste 1; jupiter FL 33477
• Manufacturer Contact: rodney crain ; 967 n. alternate a1a; ste 1; jupiter 33477 ; 5612779840
• MDR Report Key: 12865257
• Report Number: 3006082533-2021-00001
• Device Sequence Number: 13823349
• Product Code: MAX
• UDI-Device Identifier: M739PI01000
• UDI-Public: +M739PI01000/$$709160005E
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

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: PI-0100
• Device Catalogue Number: PI-0100
• Device Lot Number: 09160005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TLIF TITANIUM CAGE PIV-CVD PARALLEL 30MM X 12MM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown