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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P10.7-80X275
Device Problem Collapse (1099)
Patient Problem Failure of Implant (1924)
Event Date 09/03/2020
Event Type  Injury  
Manufacturer Narrative
The device has not been returned for evaluation. The root cause is unable to be determined at this time. If any additional information has been provided, a supplemental report will be submitted.
 
Event Description
Information was received that a revision procedure was performed to address a nail that was found to be collapsed, resulting in a loss of distraction. The surgeon believes this may be attributed to full weight bearing and the patient experiencing a fall.
 
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Brand NamePRECICE SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer Contact
geoff gannon
101 enterprise dr, suite 100
aliso viejo, CA 92656
6197314188
MDR Report Key11740989
MDR Text Key247916975
Report Number3006179046-2021-00264
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP10.7-80X275
Device Lot Number9110102
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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: 04/28/2021 Patient Sequence Number: 1
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