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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number PS11.5-65SJ250
Device Problem Material Discolored (1170)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation. The root cause is unable to be determined at this time. If any additional information is provided, a supplemental report will be submitted.
 
Event Description
Information was received that during explant the nail was found to have corrosion on the telescopic part. The nail functioned as intended and no patient adverse event was reported.
 
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Brand NamePRECICE STRYDE SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS
101 enterprise #100
aliso viejo 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS
101 enterprise #100
aliso viejo CA 92656
Manufacturer Contact
geoff gannon
101 enterprise #100
aliso viejo, CA 92656
8583448112
MDR Report Key13839925
MDR Text Key287539237
Report Number3006179046-2022-00158
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPS11.5-65SJ250
Device Lot Number9070304AAA
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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