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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
Model Number 10-07
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
There is no evidence confirming the event or the manufacturer of the device.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.
 
Event Description
Reportedly patient received spinal fusion posterior fixation from l3-l5.No index surgery details were provided.Revision was planned to tighten three loose locking screws and extend construct to s1.Revision was postponed and no further surgical information or device details were provided.
 
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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 Key12888724
MDR Text Key281406259
Report Number3004893332-2021-00022
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840916101367
UDI-Public00840916101367
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/29/2021
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
Device Model Number10-07
Device Catalogue Number10-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2020
Initial Date FDA Received11/29/2021
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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