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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)
Patient Problem Failure of Implant (1924)
Event Date 06/07/2022
Event Type  Injury  
Event Description
Reportedly patient received spinal fusion posterior fixation from l4-s1 and two level alif. Radiographs received depict fractures in both screws placed in s1. Original surgical date unknown. There was a request for revision instrumentation, but revision date is unknown.
 
Manufacturer Narrative
After multiple attempts, dhr review cannot be completed as no device information was provided. No surgical information was given. No evaluation of the device can be performed, as the device(s) were not returned. There is no evidence confirming the manufacturer of the device. Unknown factors include: implant duration, patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the progression towards spinal fusion, 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.
 
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Brand NameSAVANNAH
Type of DeviceTHORACOLUMBOSACRAL 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 Key14920809
MDR Text Key295313489
Report Number3004893332-2022-00011
Device Sequence Number1
Product Code NKB
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
Type of Report Initial
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2022
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 Treatment Data
Date Received: 07/05/2022 Patient Sequence Number: 1
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