MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON® TC; INTERBODY FUSION DEVICE

Model Number	5166-1408
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device malfunction or patient injury reported, rather the cage did not fuse.There was a non-union, but the surgeon decided to leave the device implanted and not revise the case, since revising would be more harmful to the patient.The device was found to be conforming to all specifications upon release.Serious injury was selected as the type of reportable event given the selection options.However, no patient injury was reported and no intervention (surgical or otherwise) was deemed necessary.
Event or Problem Description
It was reported by the surgeon that the operated level was not fused at the one year follow up and that the implant subsided into both of the vertebral bodies adjacent to the implant.

• Brand Name: ENDOSKELETON® TC
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): TITAN SPINE; 6140 w executive drive; ste a; mequon WI 53092
• MDR Report Key: 8739807
• Report Number: 3006340236-2019-00008
• Device Sequence Number: 16785792
• Product Code: ODP
• UDI-Device Identifier: 00191375003663
• UDI-Public: (01)00191375003663(11)150601(10)A150608(240)51661408
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 5166-1408
• Device Catalogue Number: 5166-1408
• Device Lot Number: A150608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR