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

Model Number	9411905
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: delay over 60 minutes.If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11567361
• Report Number: 1030489-2021-00402
• Device Sequence Number: 19738320
• Product Code: MQP
• UDI-Device Identifier: 00613994730107
• UDI-Public: 00613994730107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 9411905
• Device Catalogue Number: 9411905
• Device Lot Number: CA13C070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/25/2021
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 42