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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number CPA2-005
Device Problem Physical Resistance/Sticking (4012)
Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330)
Event Date 01/27/2022
Event Type  malfunction  
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.
 
Event Description
Information was received that after a successful nail implant procedure, the patient reported that they felt discomfort and it hurt to flex their knee. The surgeon determined that a revision procedure would be performed to remove the end cap that was placed. During the procedure, the surgeon was unsuccessful in removing the end cap. At a later date, a second revision procedure was performed. Multiple attempts were made to remove the end cap; however, they were unsuccessful. It was then determined that the nail would need to be removed and replaced.
 
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Brand NamePRECICE 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 Key13595310
MDR Text Key286464862
Report Number3006179046-2022-00126
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K191336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPA2-005
Device Lot Number9100861-AAE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2019
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: 02/24/2022 Patient Sequence Number: 1
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