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

Model Number	8657001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with spinal therapy.It was reported that the one of the prongs at the tip of the inserter that the cage sits in is broken.During the insertion of the interbody, surgeon expanded the interbody.After confirmation of the placement of the cage, he reattached the inserter, collapsed the cage, then advanced the cage more anteriorly and expanded the cage.Surgeon felt that the inserter was loose on the implant and observing the tip of the inserter, one of the prongs were missing.Ap and lateral xr were taken and evaluated by radiology.Also, before insertion of the interbody, it was identified that the tip of the inserter drive shaft was broken off.This instrument was not used during the procedure.There was no fragment left in the patient.There were no symptoms reported.There were no further complications reported regarding the event.

• Brand Name: ELEVATE SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 12278882
• Report Number: 1030489-2021-01016
• Device Sequence Number: 11722984
• Product Code: MAX
• UDI-Device Identifier: 00643169432178
• UDI-Public: 00643169432178
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/05/2021

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: 8657001
• Device Catalogue Number: 8657001
• Device Lot Number: EM16A014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR