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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 AGB1-000
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for evaluation. Even though root cause cannot be confirmed, reporter believes either the drill bushings/guide tubes are bent or the guide arm is damaged. With no product or pictures event cannot be confirmed.
 
Event Description
As per the reporter during the implant procedure the drill wouldn't pass through the guide and then through the nail causing a delay in therapy. No patient harm reported.
 
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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
suite 100
aliso viejo, CA 92656
6197314188
MDR Report Key9965916
MDR Text Key188694775
Report Number3006179046-2020-00270
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K173129
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAGB1-000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/15/2020 Patient Sequence Number: 1
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