• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SPINAL ELEMENTS, INC MERCURY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 63485-090
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 10/30/2020
Event Type  malfunction  
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.The device was not returned as it remains in-situ and therefore could not be evaluated.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.).Patient was noted to be morbidly obese.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 spinal fusion surgery (plif) with bilateral fixation from t10-pelvis.Initial surgery date was (b)(6) 2020.During routine follow up visit 6 weeks post-operatively, radiographs depicted a tulip/head separation from the iliac bolt on the left side.Patient is asytomatic.There is no plan for revision unless patient presents with non-union at l5-s1, or sacral fracture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10906301
MDR Text Key240379826
Report Number3004893332-2020-00013
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840606101295
UDI-Public00840606101295
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number63485-090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2018
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 Age56 YR
-
-