MAUDE Adverse Event Report: SPINAL ELEMENTS, INC ZEUS-O; INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY

Model Number	5-120928
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event radiograph received notes the implant is now located laterally, outside the disc space.Patient is asymptomatic and alif revision surgery is planned but schedule date is unknown.No patient injury is reported.No device was returned for evaluation as it remains in the patient.There is no allegation of a deficiency of the device or of the surgery.Unknown factors include: patient activity at the time or prior to the event, the degree of spinal instability, patient compliance with postoperative care instructions, or if the patient sustained a fall/impact of any sort (no trauma was reported.) root cause of the migration is unknown.
Event or Problem Description
On (b)(6) 2020, patient underwent a ollif procedure, implanting a interbody cage at l5-s1.Patient returned two weeks later for the posterior fixation procedure.The pre-operative radiograph noted the implant at l5-s1 had migrated.Patient is asymptomatic.Posterior fixation surgery was postponed.There was no allegation of a deficiency of the implant or procedure.

• Brand Name: ZEUS-O
• Common Device Name: INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad, ca
• MDR Report Key: 10298820
• Report Number: 3004893332-2020-00005
• Device Sequence Number: 19528139
• Product Code: MAX
• UDI-Device Identifier: 00840916122300
• UDI-Public: 00840916122300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5-120928
• Device Catalogue Number: 5-120928
• Device Lot Number: 140889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/20/2020
• 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: Required Intervention
• Patient Age: 57 YR