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	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other: device fragment 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 the patient underwent dfi posterior lumbar decompression with fusion and instrumentation at l4-l5 and l5-s1, with interbody prosthesis l5-s1, bmp, ebi and allograft.Intra-op, the tip on the expansion tool snapped off into the screw on the cage and remained in the back of the cage.At the time of this report, it was unknown whether there were any complication or not.

• 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: 9986850
• Report Number: 1030489-2020-00469
• Device Sequence Number: 4597159
• Product Code: MAX
• UDI-Device Identifier: 00643169432192
• UDI-Public: 00643169432192
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/22/2020
• 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: 62 YR