MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON TAS NANOLOCK SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 2312-0314-N

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Pain (1994)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight was not available.Other relevant device(s) are: product id: 2300-5530, serial/lot #: (b)(4), udi#: (b)(4); product id: 2300-5530, serial/lot #: (b)(4), udi#: (b)(4); product id: 2300-5530, serial/lot #: (b)(4), udi#: (b)(4).It was unable to be determined which of the three screws (product id: 2300-5530) was the screw that had backed out.The cage and three screws remained implanted in the patient.Therefore, no devices have been returned to the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a spinal device.It was reported that a screw backed out of the cage post-operatively.The date of the primary surgery was (b)(6) 2019 and the date the reported issue occurred was (b)(6) 2019.The primary surgery was performed to treat a grade 1 mobile slip/isthmic spondylolisthesis.The levels implanted were l5/s1.The patient returned to the hospital a couple of weeks after the primary surgery with pain.It was confirmed by imaging that a screw had backed out.As a cage and three screws were used, the lot number of the individual screw that had backed out was unable to be identified.The patient was readmitted; the patient was backed up with posterior pedicle screws and a posterior fusion was completed to stop the movement of the cage.The cage and three screws remained implanted.It was noted that the screw that backed out was being monitored.As the case was not far enough out, fusion had not been assessed.No further information was provided.

• Brand Name: ENDOSKELETON TAS NANOLOCK SURFACE TECHNOLOGY
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9826434
• MDR Text Key: 185976207
• Report Number: 3006340236-2020-00003
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00191375014270
• UDI-Public: 00191375014270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: 2312-0314-N
• Device Catalogue Number: 2312-0314-N
• Device Lot Number: TM0111721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2018
• 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): Required Intervention
• Patient Age: 77 YR