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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 P8.5-80B245
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
It was reported that allegedly the patient's precice nail would not lengthen. The physician revised the nail with a new precice nail without incident.
 
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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 Key7652507
MDR Text Key112800240
Report Number3006179046-2018-00044
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
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
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP8.5-80B245
Device Catalogue NumberP8.5-80B245
Device Lot NumberA160706-01
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 Received05/30/2018
Was Device Evaluated by Manufacturer? No
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: 06/29/2018 Patient Sequence Number: 1
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