MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TO 0 DEG LORDOTIC, CONVEX, IMPLANT, 26 X 11MM, PLIF; SPINAL FUSION IMPLANT

Model Number	3110-2611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The original case that implanted the endoskeleton® to implant occurred on (b)(6) 2015 at the (b)(6).No issues were reported with the original implantation of the endoskeleton® to implant.It is possible that the threading damage on the implant resulted from the original case and was not detected.The 6-32 unc-2b threads are located on the posterior edge of endoskeleton® to implants.These threads are a design feature of the device for insertion.This feature does not impact fusion, stability or clinical outcome of the device.Dr.(b)(6) was contacted to receive expert opinion in regards to this situation.Dr.(b)(6) concluded "the implant is placed far enough into the disc space for a fusion to have occurred.While there is some prominence noted, this failure to fuse necessitated the removal and replacement of the implant.It should be covered under our warranty program." the device history records for the implant that was explanted was reviewed.The review revealed there were no anomalies or non-conformances generated during the manufacture of the product that would contribute to this complaint condition.Device not returned.
Event or Problem Description
Surgeon was dissatisfied with the original placement and lack of fusion for an endoskeleton® to implant.During the revision surgery, the threads of the endoskeleton® to implant were discovered to be damaged.The endoskeleton® to implant was being used as an interbody fusion device with adjunct pedicle screws when the damaged threads were detected.A two level left sided approach tlif i-45 i5 s1 bilateral posterior instrumentation procedure was performed.Due to the damaged threads of the implant, tlif exploration was used for the explanation of the implant from the patient.The planned revision procedure was completed as planned with approximately a 15 minute delay due to the damaged threading on the implant.No adverse effects or injury to the patient occurred as a result of the damaged threading on the implant.
Additional Manufacturer Narrative
No issues were reported with the original implantation of the endoskeleton® to implant.Ir ia possible that the threading damage on the implant resulted from the original case and was not detected.The 6-32 unc-2b threads are located on the posterior edge of endoskeleton® to implants.These threads are a design feature of the device for insertion.This feature does not impact fusion, stability or clinical outcome of the device.(b)(4).
Event or Problem Description
Surgeon was dissatisfied with the original placement and lack of fusion for an endoskeleton® to implant.During the revision surgery, the threads of the endoskeleton® to implant were discovered to be damaged.The endoskeleton® to implant was being used as an interbody fusion device with adjunct pedicle screws when the damaged threads were detected.A two level left sided approach tlif i-45 i5 s1 bilateral posterior instrumentation procedure was performed.Due to the damaged threads of the implant, tlif exploration was used for the explanation of the implant from the patient.The planned revision procedure was completed as planned with approximately a 15 minute delay due to the damaged threading on the implant.No adverse effects or injury to the patient occurred as a result of the damaged threading on the implant.

• Brand Name: ENDOSKELETON® TO 0 DEG LORDOTIC, CONVEX, IMPLANT, 26 X 11MM, PLIF
• Common Device Name: SPINAL FUSION IMPLANT
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5982019
• Report Number: 3006340236-2016-00007
• Device Sequence Number: 569971
• Product Code: MAX
• UDI-Device Identifier: M682311026110
• UDI-Public: +M682311026110/$A140608/16D20140601I
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 3110-2611
• Device Catalogue Number: 3110-2611
• Device Lot Number: A140608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2016
• Supplement Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1