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	09/24/2019
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 underwent oblique lateral interbody fusion (olif) at l4-5 and posterior lumbar interbody fusion (plif) at l5-s1 due to spinal canal stenosis.Intra-op, after the first cage was inserted, the cage was expanded until the counter torque idled.Thereafter, the surgeon replaced the handle with a fixed egg handle for further expanding, and when performing further expanding, the tip of the inserter broke and remained in the cage.This broken tip sank into the screw on the cage side, and the surgeon judged that it was impossible to remove the tip, then wound closure was performed.
Additional Manufacturer Narrative
Additional information: product analysis results: visual and optical inspection confirmed approximately 2 mm has been sheared off.Optical inspection of the fracture surface revealed circular material flow consistent with torsional overload.The tip was not returned for analysis.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: 9224067
• Report Number: 1030489-2019-01192
• Device Sequence Number: 2374372
• Product Code: MAX
• UDI-Device Identifier: 00643169432192
• UDI-Public: 00643169432192
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 8657003
• Device Lot Number: EM16G011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR