MAUDE Adverse Event Report: SPINAL ELEMENTS, INC MERCURY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	63485-090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic imaging depicts the screw shank in the iliac has separated from the screw head (tulip) which is still attached to the rod.The device was not returned as it remains in-situ and therefore could not be evaluated.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.).Patient was noted to be morbidly obese.Root cause or specific failure mode cannot be determined.Labeling review notes: "possible adverse events.Disassembly, bending, and/or breakage of any or all of the components.Loss of fixation.".
Event or Problem Description
Patient received a spinal fusion surgery (plif) with bilateral fixation from t10-pelvis.Initial surgery date was (b)(6) 2020.During routine follow up visit 6 weeks post-operatively, radiographs depicted a tulip/head separation from the iliac bolt on the left side.Patient is asytomatic.There is no plan for revision unless patient presents with non-union at l5-s1, or sacral fracture.

• Brand Name: MERCURY
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 10906301
• Report Number: 3004893332-2020-00013
• Device Sequence Number: 14224002
• Product Code: NKB
• UDI-Device Identifier: 00840606101295
• UDI-Public: 00840606101295
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 63485-090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR