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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 PS11.5-65B250
Device Problem Material Discolored (1170)
Patient Problems Inflammation (1932); Pain (1994); Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned for evaluation. Root cause is unable to be determined at this time. Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.
 
Event Description
Information was received that a revision procedure was performed on (b)(6) 2021. As per the reporter, the patient experienced a sudden increase in pain and bone abnormalities at the junction of the telescoping nail segments. Upon explant it was noticed that the nail was corroded. No patient injury was reported.
 
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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 Key11439689
MDR Text Key238874807
Report Number3006179046-2021-00167
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPS11.5-65B250
Device Lot Number9070217
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: 03/08/2021 Patient Sequence Number: 1
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