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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 PS10.0-80D305
Device Problem Mechanical Problem (1384)
Patient Problem Failure of Implant (1924)
Event Date 02/16/2022
Event Type  malfunction  
Event Description
It was reported that the surgeon noticed the implant was broken during removal. No patient adverse event was reported.
 
Manufacturer Narrative
The device has been received and is pending evaluation. The root cause is unable to be determined at this time. A supplemental report will be submitted following the device evaluation.
 
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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 92656
8583448112
MDR Report Key13777499
MDR Text Key287249668
Report Number3006179046-2022-00154
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPS10.0-80D305
Device Lot Number0081913AAA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2000
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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