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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number PS11.5-80SJ265
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is in progress; upon completion, a follow-up medwatch will be submitted.
 
Event Description
It was reported that upon removal of the nail after it had achieved its intended purpose and outcome, it was noted that there were changes to the metal on the distal screw hole at the junction of the nail.No patient impact or adverse event was reported.
 
Manufacturer Narrative
Device records review: a review of dhr for the returned unit confirmed that it met all the required quality inspection criteria prior to release.Device evaluation: visual inspection of the returned nail revealed that the distraction rod of the nail had corrosion.The root cause cannot be determined at this time; further investigation is being conducted through the capa process.
 
Event Description
No additional event information was provided.
 
Event Description
No additional event information was provided.
 
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Brand Name
PRECICE STRYDE SYSTEM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
MDR Report Key11499571
MDR Text Key242784900
Report Number3006179046-2021-00204
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00887517951670
UDI-Public887517951670
Combination Product (y/n)N
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPS11.5-80SJ265
Device Lot Number9022115AAA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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