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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXUS SPINE, LLC PRESSON; PEDICLE SCREW

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NEXUS SPINE, LLC PRESSON; PEDICLE SCREW Back to Search Results
Model Number 520225
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: pedicle screw disassembled.The pedicle screw removed showed damage possibly due to a bone removal instrument.Other remarks: complaint follow-up from remediation activities resulting in late filing.
 
Event Description
Patient hospitalized for removal and replacement of disassembled pedicle screw.
 
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Brand Name
PRESSON
Type of Device
PEDICLE SCREW
Manufacturer (Section D)
NEXUS SPINE, LLC
2825 e cottonwood pkwy ste 330
salt lake city UT 84121
MDR Report Key17725914
MDR Text Key323146342
Report Number3011390763-2022-00001
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
160820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 01/16/2022
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? No
Device Operator Health Professional
Device Model Number520225
Device Catalogue Number5220225
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/11/2023
Was Device Evaluated by Manufacturer? Yes
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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