MAUDE Adverse Event Report: HT MEDICAL TI3D STRAIGHT LUMBAR; INTERBODY CAGE

Model Number	23-LCT-2509
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device batch records and acceptance activity were reviewed on 29oct2020 for the interbody implant lot; device lot released on 04/06/2020.Sterile expiration date: 2027-01-01.No anomalies were found related to the reported problem.To date, items of the same lot have been sold without any similar reported event.In the initial surgery another manufacturer's parallel sizer instrument was utilized for selection of the lordotic interbody implant size.It was reported that the patient had very parallel end plates, which would necessitate posterior supplemental fixation for compression of the lordotic implant to prevent migration or alternatively utilizing a non-lordotic implant for this patient anatomy.Revision surgery was performed on the patient and the existing (quantity: 2) lumbar interbody implants were tamped back into position and another manufacturer's fixation system compressed and re-tightened for lordosis.There were no further patient complications reported.There is no indication that the adverse event was caused by any defect of the device.Note: there was a delay in submitting this mdr due to production account approval through the fda webtrader portal process.
Event or Problem Description
Initial surgery was performed on (b)(6) 2020 for plif single level fusion at l5-s1 without final posterior compression of supplemental fixation.Posterior movement of interbody implants discovered about (6) weeks after original surgery implantation.Revision surgery performed to tamp the interbody implants back into the disc space anteriorly and then compress on the screws to increase the lordosis and increase endplate contact with implant.Surgical revision procedure was completed without issue and patient discharged in normal course.

• Brand Name: TI3D STRAIGHT LUMBAR
• Common Device Name: INTERBODY CAGE
• Manufacturer (Section D): HT MEDICAL; 450 south orange avenue; third floor; orlando FL 32801
• MDR Report Key: 10848596
• Report Number: 3012429289-2020-00001
• Device Sequence Number: 14257185
• Product Code: MAX
• UDI-Device Identifier: 00818345024380
• UDI-Public: 00818345024380
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 23-LCT-2509
• Device Catalogue Number: 23-LCT-2509
• Device Lot Number: WAAM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 11/16/2020
• 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: 53 YR