Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
  • 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, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY Back to Search Results
Model Number GSB1-000
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/17/2020
Type of Reportable Event Malfunction
Additional 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 or Problem 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Common Device Name
FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key9965743
Report Number3006179046-2020-00268
Device Sequence Number14371557
Product Code HSB
UDI-Device Identifier00812258022075
UDI-Public812258022075
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K173129
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberGSB1-000
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/18/2020
Initial Report FDA Received Date04/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-