MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	8657003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: other - fragments of the instrument remains in patient.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 underwent lumbar fusion surgery at l3-s1 due to lumbar stenosis.Intra-op, since the tech nurse assembled the wrong egg handle to the inserter as a result of that when surgeon expanded the implant he was expecting the torque limiter to click, instead the tip of the instrument snapped off into the back of the implants.Many attempts were made to try to remove it, but were unsuccessful.The doctor felt that the tip was well embedded in the implant and would be safe to leave.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis result: visual and optical inspection revealed that the screw driver shield's weld has broken.The weld is not very robust but is only required to hold 6nm per the print.There are witness marks on the underside of the shield to indicate pressure was applied.The tip appears to have been sheared and is missing.This is consistent with overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ELEVATE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9493727
• Report Number: 1030489-2019-01442
• Device Sequence Number: 1541803
• Product Code: MAX
• UDI-Device Identifier: 00643169432192
• UDI-Public: 00643169432192
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• 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,Followup
• Report Date (Section B): 04/03/2020

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: 8657003
• Device Lot Number: EM16A012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 04/03/2020
• 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: Other
• Patient Age: 50 YR