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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); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/24/2021
Event Type  Injury  
Manufacturer Narrative
The device was not made available for evaluation and the device lot number was not provided. The root cause is unable to be determined. If any relevant additional information is provided, a supplemental report will be submitted. Literature citation: rolfing, jan duedal, et al (2021). Pain, osteolysis, and periosteal reaction are associated with the stryde limb lengthening nail: a nationwide cross-sectional study. Acta orthopaedica, volume 92. Web address to article: https://doi. Org/10. 1080/17453674. 2021. 1903278.
 
Event Description
Information was received via review of literature that a removal procedure was performed on an unknown date due to valgus malalignment. As per the reporter, the patient also experienced osteolysis and periosteal reaction. No additional information is available.
 
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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
geoff gannon
101 enterprise dr, suite 100
aliso viejo, CA 92656
MDR Report Key11682390
MDR Text Key245974797
Report Number3006179046-2021-00249
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
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 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received03/24/2021
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: 04/16/2021 Patient Sequence Number: 1
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