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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINAL ELEMENTS, INC SAVANNAH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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SPINAL ELEMENTS, INC SAVANNAH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Fracture (1260); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
No surgical information was given.Dhr review cannot be completed as no device information has been received.No evaluation of the device can be performed, as the device(s) were not returned.Unknown factors include: implant duration, 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.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
Reportedly on (b)(6) 2020, a patient with a posterior fixation (t7-l4) had loose lock screws at l4 and possible pedicle bone screw fractured.Revision reportedly occurred on (b)(6) 2020.No further event details were given.Patient status is unknown.
 
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Brand Name
SAVANNAH
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 Key10876059
MDR Text Key219566318
Report Number3004893332-2020-00012
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K152920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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