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

Model Number	62085-040
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only source of information was through fda voluntary medwatch (b)(4).Device is not available for evaluation.Additionally, no event radiographs of the device were provided for analysis.
Event or Problem Description
In response to voluntary medwatch report (b)(4) received from fda, patient underwent l4-s1 lumbar fusion surgery on (b)(6) 2022.It was reported that the s1 screw had fractured after six months on (b)(6) 2022.The shank of the 8.5mm bone screw, remains in the patient.

• Brand Name: MERCURY
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 15889860
• Report Number: 3004893332-2022-00014
• Device Sequence Number: 14754944
• Product Code: NKB
• UDI-Device Identifier: 00840606117890
• UDI-Public: 00840606117890
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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: 62085-040
• Device Catalogue Number: 62085-040
• Device Lot Number: 140040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown