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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
Model Number 62085-040
Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 11/07/2022
Event Type  Injury  
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 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.
 
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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 Key15889860
MDR Text Key304602157
Report Number3004893332-2022-00014
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840606117890
UDI-Public00840606117890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number62085-040
Device Catalogue Number62085-040
Device Lot Number140040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2014
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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