MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TAS 6.5 DIA, STANDARD BONE SCREW, 30MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2300-6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 22-feb-2018 as regulatory report # 3006340236-2017-00016 ¿ 1.Per request, it is being resubmitted as an initial report.Event date is approximated as it was reported to have occurred 6-7 weeks after the original surgery.An exact incident date was not provided.The screw failure occurred as a result of implant subsidence and failure of the vertebral body resulting in the head of the screw being pushed downwards by the implant while the threaded tip remained stationary fixated in the bone.It was unable to be determined what directly caused the screw to fracture post-operatively.It is expected that the failure was contributed to by the lack of supplemental fixation and/or patient noncompliance to the surgeon's post-operative instruction.After reviewing the patient's post-operative fluoroscopy images, dr.(b)(6) ((b)(6) chief medical officer) stated that the l4-l5 alif level is a very mobile region, especially for a patient with grade 1-2 spondylolisthesis.Thus, while supplemental fixation is not required for (b)(6) system, it should have been used to ensure stability of the region for this patient.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, post-operatively, a bone screw fractured inside a patient.The original l4-l5 surgery was performed on (b)(6) 2017, and the reported issue occurred approximately 6-7 weeks after the surgery.An exact incident date was not provided.The patient, who the surgeon described as having "good bone quality," was reportedly doing well 4 weeks after the surgery.After about 6 weeks, the patient started to present acute back pain.X-rays were taken to discover a broken screw.The patient was put under lumbar bone stimulation, and the surgeon stated that he thought "the patient would be fine as long as no other slip or cage displacement occurred." it was stated that there had been no revision surgery for supplemental fixation and the screw remained inside the patient.

• Brand Name: ENDOSKELETON® TAS 6.5 DIA, STANDARD BONE SCREW, 30MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w. executive dr. suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7290736
• Report Number: 3006340236-2017-00016
• Device Sequence Number: 11467636
• Product Code: OVD
• UDI-Device Identifier: 00191375001874
• UDI-Public: 00191375001874
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K111626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: Health Professional
• Device Model Number: 2300-6530
• Device Catalogue Number: 2300-6530
• Device Lot Number: V18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 60 YR
• Patient Sex: Female