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

Model Number	2312-0314-N
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• MDR Report Key: 9826434
• Report Number: 3006340236-2020-00003
• Device Sequence Number: 11117285
• Product Code: OVD
• UDI-Device Identifier: 00191375014270
• UDI-Public: 00191375014270
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR