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

Model Number	436120C
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient spinal therapy for first lumbar burst fracture.It was reported that the product contracted after placing it into t3 and final fixing was performed.They had to reinsert a new implant and completed the procedure.No further complications or symptoms were reported.Additional information was received via manufacturer representative that the endcaps have no malfunction.Even if the centerpiece was expanded, it could not be fixed in the expanded state.When it was took out of the surgical field and fixed with the set screw without stress, it could not maintain the expanded state.
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 manufacturer representative regarding a patient spinal therapy for first lumbar burst fracture.It was reported that the product contracted after placing it into t3 and final fixing was performed.They had to reinsert a new implant and completed the procedure.No further complications or symptoms were reported.Additional information was received via manufacturer representative that the endcaps have no malfunction.Even if the centerpiece was expanded, it could not be fixed in the expanded state.When it was took out of the surgical field and fixed with the set screw without stress, it could not maintain the expanded state.

• 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: 13598539
• Report Number: 1030489-2022-00192
• Device Sequence Number: 5947082
• Product Code: MQP
• UDI-Device Identifier: 00643169634862
• UDI-Public: 00643169634862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 436120C
• Device Catalogue Number: 436120C
• Device Lot Number: CA19L058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/25/2022
• Date Device Manufactured: 07/21/2020
• 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
• Patient Sex: Unknown