MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON TCS; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	5302-3514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier and patient weight were not available.The subject device has not been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a spinal device being used for a 3 level anterior cervical discectomy and fusion (acdf) case.The acdf procedure was being performed to treat spinal stenosis, and the levels implanted were c4/5, c5/6, and c6/7.It was reported that during the procedure the locking screw's locking cap sheared off the screw.The surgeon tried inserting the locking screw into the c4/5 body.After using a curved free hand awl into the device, the surgeon drove the locking screw through the spacer into the bone.Upon reaching the lip of the spacer, the locking cap sheared off the screw and into the incision site.Everything was recovered, and the cap and screw shaft were removed from the patient, confirmed by fluoroscopic imaging.No further problems arose thereafter.The curved variable awl was used to make a new trajectory, and a new screw was inserted into the new trajectory.There were no patient symptoms or complications, and there was no additional treatment or surgery performed as a result of this event.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDOSKELETON TCS
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• MDR Report Key: 9811617
• Report Number: 3006340236-2020-00002
• Device Sequence Number: 2704513
• Product Code: OVE
• UDI-Device Identifier: 00191375011507
• UDI-Public: 00191375011507
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: 5302-3514
• Device Catalogue Number: 5302-3514
• Device Lot Number: V46
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR