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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Osteomyelitis (4533); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned for evaluation and the device lot number was not made available. Root cause is unable to be determined at this time.
 
Event Description
Information was received that a patient experienced mild hyperostosis, swelling, and pain at the caliber change. Additionally, a revision procedure was performed on an unknown date due to suspected chronic osteomyelitis.
 
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Brand NamePRECICE STRYDE 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 Key11457477
MDR Text Key239100400
Report Number3006179046-2021-00182
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/11/2021
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: 03/10/2021 Patient Sequence Number: 1
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