MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 9412500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse event: delay of over 60 min.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturing representative regarding patient with l3/4 vertebral body collapse suggested for spinal therapy.Posterior fixation was performed at l1-s2.Levels implanted was l3- 4.Event occurred intra-op.It was reported that l3/4 vertebral subtotal removal was performed and the reported implants were placed.The cage was lengthened after being inserted between the vertebral bodies, but it shrank before it was fully lengthened.When the cage was checked outside the operative field, it could be lengthened to the end without any problem, but the same event was confirmed in the operative field.It was attempted to lengthen the cage by inserting an adjuster into the opening for filling bone graft, but the cage couldn't be lengthened until the end.Therefore, the cage was replaced with another one with one increased size.The torque limiting driver was not used.Delay of over 60 minutes was reported.Implant was explanted and being returned.No patient symptoms or further complications was reported.No defect was found in inserter in appearance.Lot#ca12g066 and ca12j027 of pinion driver had scratches at tip.Ca13f029-b had scratches at tip.Ca13f029-a had no problem in appearance threads of these two racks had a little damage.Adjust had no defect in appearance.The product worked smoothly and could extend t2 cage to the fullest.

• Brand Name: T2 SPINAL SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11567328
• MDR Text Key: 242181902
• Report Number: 1030489-2021-00397
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994683557
• UDI-Public: 00613994683557
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9412500
• Device Catalogue Number: 9412500
• Device Lot Number: CT12E041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 42