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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 P10.7-80B335
Device Problems Break (1069); Component or Accessory Incompatibility (2897)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
The device remains implanted in the patient. Therefore, it was not returned for evaluation. However, x-ray images were provided, and the nail appeared to have broken in the crown area.
 
Event Description
It was reported that allegedly the patient fell. A x-ray was done and it revealed loss of distraction of the precice nail. The physician has not plans to remove the nail at this time.
 
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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
karen jaffe
101 enterprise, suite 100
aliso viejo, CA 92656
9495446507
MDR Report Key8375778
MDR Text Key139196822
Report Number3006179046-2019-00023
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
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 02/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberP10.7-80B335
Device Catalogue NumberP10.7-80B335
Device Lot NumberA170223-06-0AA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

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