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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY

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NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY Back to Search Results
Model Number P10.7-80C245
Device Problem Failure to Advance (2524)
Patient Problem Failure of Implant (1924)
Event Date 01/31/2020
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation nor were radiographs or images provided to confirm the alleged event. No root cause can be confirmed at this time.
 
Event Description
Information was received that a revision procedure was performed on (b)(6) 2020. As per reporter the nail was not lengthening.
 
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Brand NamePRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Type of DeviceFIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
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
tiara rae
101 enterprise
aliso viejo, CA 92656
MDR Report Key9758606
MDR Text Key182913905
Report Number3006179046-2020-00118
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173129
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 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP10.7-80C245
Device Lot Number8070208AAA
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 Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/26/2020 Patient Sequence Number: 1
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