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

Model Number	436113D
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with a centerpiece and anterior plate zevo in a somatectomy.It was reported that during the first surgery on (b)(6) 2022, the cage didn't maintain the expansion, so it was replaced with another cage using the two endplates to give lordosis.The endplate had difficulties to assemble the central piece during the same surgery.1 day post-op, the patient reported the sensation of ¿crunching¿ at the cervical level.Following diagnostic imaging, it was found that the cranial endplate had lost the lordosis determined during the surgery.The dynamometric closure of the nut inherent in the definitive positioning of the cranial endplate took place without any problem.No revision was made.On the (b)(6) 2022, it was reported that following a domestic quarrel without a collar, the patient underwent two frontal falls with relative loss of consciousness.After recovering from the second fall, tetraplegia was found.Upon arrival in the facility, the diagnostic images revealed implant mobilization.On (b)(6) 2022, a revision surgery was made to remove the medical devices.While removing the implant, there was loss o f lordosis determined during the first surgery as patient symptom.The procedural time of the first surgery was delayed due to malfunction of the first cage and difficulty in assembling the end plates.The patient had mild mental retardation.There were no further complications reported regarding the event.

• Brand Name: T2 STRATOSPHERE¿ EXPANDABLE CORPECTOMY SYSTEM
• Common Device Name: 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13521310
• Report Number: 1030489-2022-00143
• Device Sequence Number: 4385369
• Product Code: MQP
• UDI-Device Identifier: 00643169634824
• UDI-Public: 00643169634824
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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: 436113D
• Device Catalogue Number: 436113D
• Device Lot Number: CA19L054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/14/2022
• Date Device Manufactured: 09/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG