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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P10.7-50K190
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was alleged that a patient's precice nail was not lengthening, the nail was revised with a new precice nail, without incident.
 
Event Description
It was reported that allegedly the patient's magec rod screws appeared to have substance. Physician removed the substance from the screws, and re-implanted the magec rod in the patient without incident, and physician stated no malfunction of the magec rod.
 
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Brand NamePRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise, suite 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise, suite 100
aliso viejo CA 92656
Manufacturer Contact
carol bleakley
101 enterprise, suite 100
aliso viejo, CA 92656
MDR Report Key7258498
MDR Text Key108532864
Report Number3006179046-2018-00012
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K141023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP10.7-50K190
Device Catalogue NumberP10.7-50K190
Device Lot NumberA160524-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
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: 02/08/2018 Patient Sequence Number: 1
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