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U.S. Department of Health and Human Services

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

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NEXUS SPINE, LLC PRESSON; PEDICLE SCREW SYSTEM Back to Search Results
Model Number 520621
Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 06/14/2022
Event Type  Injury  
Manufacturer Narrative
The radiographs provided confirm the reported event.On the left side, the 22mm hybrid coupler [p/n 520611, lot h064698] pulled apart from the devices cranial and caudal to it.On the right side, the 18mm hybrid coupler [p/n 520609, lot 061295] stayed joined to the 28mm tele rod [p/n 520621, lot 060783] but the two pulled apart from the devices cranial and caudal to them.The explanted devices were not returned to allow for further evaluation; therefore, a root cause cannot be determined.Dhr review - no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to the event.Parts met acceptance criteria upon release.
 
Event Description
Patient hospitalized for removal of disassembled rod couplers.
 
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Brand Name
PRESSON
Type of Device
PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NEXUS SPINE, LLC
2825 e cottonwood pkwy ste 330
salt lake city UT 84121
Manufacturer (Section G)
PRECISION MEDICAL TECHNOLOGIES
2059 n. pound drive west
warsaw IN 46582
Manufacturer Contact
jared crocker
2825 e cottonwood pkwy ste 330
salt lake city, UT 84121
8017028592
MDR Report Key15028932
MDR Text Key295987990
Report Number3011390763-2022-00003
Device Sequence Number1
Product Code MNI
UDI-Device IdentifierB6785206210
UDI-PublicB6785206210
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
160820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/14/2022
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 Number520621
Device Catalogue Number5220621
Device Lot Number060783
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/14/2022
Initial Date FDA Received07/15/2022
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;
Patient Age75 YR
Patient SexFemale
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