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

Catalog Number 436120450

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Product was not 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 Description

It was reported that the patient presented with kyphoscoliosis; and underwent anterior fixation and oblique lumbar interbody fusion at l1-l3 and vertebral body replacement of l4.From the third day after anterior fixation, the patient had been allowed to walk only when she went to the toilet.On checking the x-ray on the fourth day post-op, it was confirmed that the self-adjusting endcap was moving, due to which, the correction had returned a little.At the time of posterior fixation performed on (b)(6) 2019, a correction was tried to be performed again during compression from the posterior side.As the bone quality was poor, the correction rate was not good.No patient complications have been reported due to this event now.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The adjustable end cap had not been locked after final tightening.

• Brand Name: T2 STRATOSPHERE EXPANDABLE CORPECTOMY 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9517752
• MDR Text Key: 181960821
• Report Number: 1030489-2019-01477
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00643169638426
• UDI-Public: 00643169638426
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 436120450
• Device Lot Number: CA18G034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/25/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR