MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH TI CONC BULLET LORD 9X11X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	196923511
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the images attached to the pc titled.The images were reviewed, and the complaint condition can be confirmed.The concorde bullet implant in the patient migrated out of the original location.There was no lot number provided, therefore a manufacturing record evaluation cannot be performed.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as received condition could not be assessed, and a dimensional inspection and document/specification review were not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review - there was no lot number provided, therefore a manufacturing record evaluation cannot be performed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on august 25, 2021, a patient previously operated with right leg pain.Ct imaging indicated the concorde bullet titanium cage had migrated posteriorly beyond the endplates resulted in a revision surgery.The surgeon re-advanced the cage to the anterior aspect of the disc space and rotated the cage such that the longitudinal axis of the cage is aligned with the coronal plane using various instruments including concorde inserter, inserter's stylet, concorde tamp, a bone funnel tamp, and downward curettes.The surgeon also loosened the construct, compress posteriorly, and re-tighten the construct to prevent future migration of the cage.Concomitant device reported: concorde inserter (part# unknown, lot# unknown, quantity unknown).Inserter's stylet (part# unknown, lot# unknown, quantity unknown).Concorde tamp (part# unknown, lot# unknown, quantity unknown).Curette (part# unknown, lot# unknown, quantity unknown).This report is for one (1) ti conc bullet lord 9x11x23.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI CONC BULLET LORD 9X11X23
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12519131
• Report Number: 1526439-2021-02062
• Device Sequence Number: 4232045
• Product Code: MAX
• UDI-Device Identifier: 10705034454368
• UDI-Public: (01)10705034454368
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 196923511
• Device Catalogue Number: 196923511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CONCORDE INSERTER; UNKNOWN CONCORDE TAMP; UNKNOWN CURETTE; UNKNOWN INSERTER'S STYLET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR