MAUDE Adverse Event Report: TITAN SPINE, INC. ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	84332408
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Fever (1858)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 having plif spinal the rapy at l4/5 for lcs.It was reported that approximately 2 mm the cage backed out.As an additional surgery the cage was removed and ilium inserted.The screws on both sides of l5 became loose.The patient has a fever and is suspected of being infected.There was no further information reported.

• Brand Name: ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: 13058540
• Report Number: 3006340236-2021-00030
• Device Sequence Number: 19805340
• Product Code: MAX
• UDI-Device Identifier: 00763000202873
• UDI-Public: 00763000202873
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: 84332408
• Device Catalogue Number: 84332408
• Device Lot Number: TM0129363
• 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: 11/29/2021
• Initial Report FDA Received Date: 12/22/2021
• Date Device Manufactured: 11/03/2020
• 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: Required Intervention
• Patient Sex: Male