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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006340236-2022-00004
• Device Sequence Number: 11943551
• Product Code: OVD
• UDI-Device Identifier: 00191375037040
• UDI-Public: 00191375037040
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K191581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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 Expiration Date: 06/02/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/23/2022
• Date Device Manufactured: 06/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 136 KG