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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned for evaluation. Root cause is unable to be determined at this time. The reported event has been addressed in the device labeling.
 
Event Description
Information was received via a clinical study that a patient experienced inconsistent lengthening due to the inability to locate the magnet. No revision information was provided. No patient injury was reported.
 
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Brand NamePRECICE SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer Contact
tiara rae
101 enterprise dr, suite 100
aliso viejo, CA 92656
6197314188
MDR Report Key11336215
MDR Text Key232162921
Report Number3006179046-2021-00128
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study,use
Reporter Occupation
Type of Report Initial
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/18/2021
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 Treatment Data
Date Received: 02/16/2021 Patient Sequence Number: 1
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