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

Model Number	63585-080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/28/2020
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.During the review of dhr, it was concluded that the product was inspected and accepted for use by quality control department and met all specified parameters of the quality inspection process (qip) with no associated nonconformance specific to this product issue.Returned device was visually inspected, functionally tested and the complaint was confirmed.The device tulip was forcibly separated from the bone screw shank.The device otherwise meets dimensional specifications except in the areas of damage which cannot be accurately measure.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 (patient was noted to be a rocker and mover) or if the patient sustained a fall/impact of any sort (no trauma was reported.).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 (tlif l4-l5) with bilateral fixation from t9-iliac.Initial surgery date was (b)(6) 2019.On (b)(6) 2020 revision surgery was performed to adjust the rod.Patient was noted to not be compliant with post-operative care instructions.An audible pop was heard by the patient's father.On (b)(6) 2020 radiographs depicted the right tulip disassociated from the right iliac shank head.Revision surgery on (b)(6) 2020 was performed to replace the screw.

• 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: 10702205
• Report Number: 3004893332-2020-00010
• Device Sequence Number: 3258839
• Product Code: NKB
• UDI-Device Identifier: 00840606101875
• UDI-Public: 00840606101875
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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 Model Number: 63585-080
• Device Lot Number: 171395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/19/2020
• 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: 29 YR
• Patient Weight: 52