• 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 STRYDE 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 STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number PS11.5-80B280
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
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 is provided, a supplemental report will be submitted.
 
Event Description
Information was received that upon routine explant of the nail after the nail had successfully performed its intended treatment, it was noted the nail had signs of corrosion around the junction. There was no adverse patient impact as a result of the reported issue and the patient successfully achieved lengthening/bone consolidation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRECICE STRYDE SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, ste 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, ste 100
aliso viejo CA 92656
Manufacturer Contact
geoff gannon
101 enterprise dr, ste 100
aliso viejo, CA 92656
8583448112
MDR Report Key13087578
MDR Text Key282774005
Report Number3006179046-2021-00523
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPS11.5-80B280
Device Lot Number9120209
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-