• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P10.7-80D245
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Discomfort (2330)
Event Date 08/01/2018
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 via isp tecnovigilancia stating that a patient was operated on with an endo medullary nail for femoral lengthening. The device was removed at 7 months due to discomfort in the trochanteric region due to prominent emc. The device was effectively used and no adverse events associated with this device were recorded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
8583448112
MDR Report Key12053360
MDR Text Key258015661
Report Number3006179046-2021-00319
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K191336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP10.7-80D245
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2021
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: 06/23/2021 Patient Sequence Number: 1
-
-