MAUDE Adverse Event Report: TITAN SPINE, INC. ENDOSKELETON¿ TL INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F

Model Number 7116-0512-N

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Outcomes attributed to adverse event: other : revision surgery scheduled.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient for dlif spinal therapy at l2-5.It was reported that broken cage remains in patient.  there was fragment of the implant or instrument remaining in the patient. there was no patient symptom reported.There were no further complications reported regarding the event.Additional information received states that revision surgery scheduled and there was no delay in initial surgery.

Manufacturer Narrative

Outcomes attributed to adverse event: other : revision surgery scheduled.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient for dlif spinal therapy at l2-5.It was reported that broken cage remains in patient.  there was fragment of the implant or instrument remaining in the patient. there was no patient symptom reported.There were no further complications reported regarding the event.Additional information received states that revision surgery scheduled and there was no delay in initial surgery.

• Brand Name: ENDOSKELETON¿ TL INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F
• Manufacturer (Section D): TITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13582684
• MDR Text Key: 285981556
• Report Number: 3006340236-2022-00004
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00191375037040
• UDI-Public: 00191375037040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7116-0512-N
• Device Catalogue Number: 7116-0512-N
• Device Lot Number: TM0133651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 136 KG