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

Catalog Number	436020D
Medical Device Problem Codes	Peeled/Delaminated (1454); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and optical examination of the centerpiece revealed a few of the gear teeth of the centerpiece have been broken off.Functional inspection of the sliding end cap confirmed it is jammed and will no longer function correctly.It appears the biologics that were used during the procedure caused the centerpiece to jam and break the teeth of the sliding end cap.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Procedure: corpectomy pre-operative diagnosis: trauma burst fracture implanted level: l3 it was reported that on (b)(6) 2018, intra-op, stratosphere cage stripped.The product came in contact with the patient.It appeared that some metal may have peeled off.No fragment of the implant or instrument remaining in the patient.No patient complications were reported.

• 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: 7882318
• Report Number: 1030489-2018-01249
• Device Sequence Number: 1940252
• Product Code: MQP
• UDI-Device Identifier: 00643169663190
• UDI-Public: 00643169663190
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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 Catalogue Number: 436020D
• Device Lot Number: CA17J058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR