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

Model Number	62075-050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was evaluated and no deviations or discrepancies were observed.Radiographs were received depicting the event.Returned device was evaluated and the complaint was confirmed.Device met specifications except in the area of damage which could not be fully measured.The screw head was disassociated from the bone shank.Marring and material deformation evidence suggests that the material yielded during separation of components as a result of excessive forces.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.Root cause or specific failure mode cannot be determined.Labeling review notes: "possible adverse events: 2.Disassembly, bending, and/or breakage of any or all of the components.3.Loss of fixation.".
Event or Problem Description
In late (b)(6) 2019, patient (diagnosed with pseudarthrosis) underwent revision surgery to remove (competitive implant hardware) left fractured bone screw and replaced with right side, unilateral hardware from l4-s1.During routine two week post-op follow up, radiographic imaging depicted pedicle bone screw head separation from right shank at s1.Approximately two weeks later, revision surgery was performed to remove replace the right s1 screw and add supplemental fixation (adjacent rod and iliac screw).Post-revision patient is reportedly doing well.

• 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: 9218773
• Report Number: 3004893332-2019-00008
• Device Sequence Number: 16690085
• Product Code: NKB
• UDI-Device Identifier: 00840606117791
• UDI-Public: 00840606117791
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K083230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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 Model Number: 62075-050
• Device Lot Number: 170911
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/22/2019
• 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: 31 YR
• Patient Weight: 100