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

Model Number	63595-100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device depicted in the radiograph as loose from the left rod was returned for evaluation.The left device is intact with no damage and meets specifications.The returned device from the right side has tulip head that has disassembled from the shank.The marring/damage suggest the disassociation maybe the result of a prying force.The complaint was confirmed.Both devices meet dimensional specifications.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.).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 with bilateral fixation from t9-pelvis.Initial surgery date was (b)(6) 2020.On (b)(6) 2020 radiographs depicted the left iliac screw loose from the rod and the right tulip disassociated from the right shank head.Revision surgery on (b)(6) 2020 replaced both screws and added secondary pelvic screws as well as satellite cocr rods.

• Brand Name: MERCURY
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad, ca
• MDR Report Key: 10298844
• Report Number: 3004893332-2020-00006
• Device Sequence Number: 2655625
• Product Code: NKB
• UDI-Device Identifier: 00840606102117
• UDI-Public: 00840606102117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: 63595-100
• Device Lot Number: 191890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• 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: 62 YR
• Patient Weight: 122