• 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 BONE TRANSPORT 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 BONE TRANSPORT SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number BT115-10SJ360-7
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
No product has been returned for evaluation. Radiographs provided confirmed the alleged event. No root cause can be confirmed at this time.
 
Event Description
Information was received that a removal surgery was completed in (b)(6) of 2019. As per reporter, the patient developed an infection (non-implant related) and the surgeon needed to remove the nail and put on external fixation. A few days later, for follow up of the external fixation pins, it was observed on x-rays that the bone transport nail had disassociated during the removal process and some of the components were left behind in the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECICE BONE TRANSPORT SYSTEM
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
tiara rae
101 enterprise
suite 100
aliso viejo, CA 92656
6197314188
MDR Report Key9298653
MDR Text Key166128225
Report Number3006179046-2019-00173
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182170
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 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model NumberBT115-10SJ360-7
Device Catalogue NumberBT115-10SJ360-7
Device Lot Number9030706AAA
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 Received04/10/2020
Was Device Evaluated by Manufacturer? Yes
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: 11/08/2019 Patient Sequence Number: 1
-
-