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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 P10.7-80D305
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Event Description
It was reported that the patient's precice nail allegedly separated after over one (1) year of implantation.The physician explanted the nail without incident.
 
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Brand Name
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
Type of Device
ROD, 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
john mcintyre
101 enterprise, suite 100
aliso viejo, CA 92656
MDR Report Key6658134
MDR Text Key78103073
Report Number3006179046-2017-00031
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K131677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberP10.7-80D305
Device Lot NumberA150304-06-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/21/2017
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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