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U.S. Department of Health and Human Services

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

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SPINAL ELEMENTS, INC MERCURY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 12/10/2018
Event Type  malfunction  
Manufacturer Narrative
Dhr review cannot be completed at this time as not product information has been provided.No product has been returned for evaluation.Received radiographs depicting two bone screws fractured mid shaft at s1.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.Duration of implantation (related to device fatigue) or progression towards bony fusion is unknown.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 Description
Patient received a posterior lateral spinal fusion surgery at l4-s1 with bilateral fixation.No interbodies appear to be used.Initial surgery date unknown.On (b)(6) 2018 radiograph depicted both bone screws at s1 to be fractured.Revision surgery is planned to replace the screws.
 
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Brand Name
MERCURY
Type of Device
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 Key8192264
MDR Text Key131384684
Report Number3004893332-2018-00007
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083230
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/10/2018
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received12/21/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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