MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON® TO; SPINAL IMPLANT

Model Number	3114-2611-N
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The case was a 2-level l4/5 and l5/s1 fusion both with endoskeleton® to cages.The cage at l4/5 was identified to have migrated posteriorly approximately 1 month after the initial procedure.On (b)(6) 2019, the cage was successfully re-seated in the disc space by impaction and additional compression was provided by making adjustments to the supplemental fixation (rods).Exact cause of migration could not be determined.Device history records were reviewed, showing that there were no issues related to the manufacture of the device and all specifications were met.
Event or Problem Description
At a follow-up with a patient who received an endoskeleton® to implant on (b)(6) 2019 (date of original surgery), it was identified that the cage migrated outside the disc space.

• Brand Name: ENDOSKELETON® TO
• Common Device Name: SPINAL IMPLANT
• Manufacturer (Section D): TITAN SPINE; 6140 w executive dr; ste. a; mequon WI 53092
• MDR Report Key: 8969616
• Report Number: 3006340236-2019-00009
• Device Sequence Number: 10846519
• Product Code: MAX
• UDI-Device Identifier: 00191375013600
• UDI-Public: (01)00191375013600(11)180404(17)221003(10)TM0106861(240)31142611N
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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 Expiration Date: 10/03/2022
• Device Model Number: 3114-2611-N
• Device Catalogue Number: 3114-2611-N
• Device Lot Number: TM0106861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR