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

Catalog Number	436120C
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
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
It was reported that the patient presented with l4 osteoporotic vertebral fracture.The patient also had degenerative lumbar scoliosis, the bone quality was weak and the upper end plate of l5 had injury.The patient underwent replacement of l4 vertebral body and anterior fixation.Percutaneous pedicle screw fixation (pps) was performed, with another manufacturer products, from the posterior approach.Three days, post-op, the implanted cage backed out.It was confirmed that the upper end plate of l5 was in a shape that it was sinking diagonally (the entry side was wide and the contralateral side was narrow).The posterior pps, which was performed using another manufacturer products, was also evaluated as unsatisfactory in efficacy.The patient did not have any symptoms, and the symptoms had recovered compared to before the operation, but the patient was evaluated as unable to withstand rehabilitation.Hence, it was decided to perform a re-operation.Patient underwent revision surgery for cage removal, and fixation was performed again.The cage was replaced with another one of size c from anterior side; and placement was done without problems.

• 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
• MDR Report Key: 10027829
• Report Number: 1030489-2020-00503
• Device Sequence Number: 19026809
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 436120C
• Device Lot Number: CA19C075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 05/06/2020
• 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: 82 YR