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

Model Number	8657002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: part # 8657002, lot # em16h013.Visual and optical inspection confirmed the instrument is broken several threads down from the distal tip of the rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of fatigue consistent with overload.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the healthcare professional via manufacturer representative regarding an event that occurred during an l3-4-5-1 tlif procedure in a patient diagnosed with spinal cord stenosis.It was reported that the threads were broken.Product was returned, and it will be replaced with a medtronic product.No patient injury / complications were reported.

• 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: 10910526
• Report Number: 1030489-2020-01701
• Device Sequence Number: 16905025
• Product Code: MAX
• UDI-Device Identifier: 00643169432185
• UDI-Public: 00643169432185
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 11/26/2020

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: 8657002
• Device Catalogue Number: 8657002
• Device Lot Number: EM16H013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 77