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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
Device Problem Material Discolored (1170)
Patient Problems Bacterial Infection (1735); Erythema (1840); Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain. Device evaluation provided by (b)(4): corrosion scoring mild to no corrosion at the extendable junction and moderate to severe corrosion at the screw nail holes. Surface damage patient showed evidence of surface damage across all screw-nail holes in both nails.
 
Event Description
Information was received that the patient presented with tibial pain and erythema 6 months post-implantation which resolved with flucloxacillin and removal of the distal locking screws. Reportedly, there are radiological changes at the male/female junction of the nail, not the regenerate. As per the surgeon, he believes that as the nail is forced out there will be a release of some debris which causes a foreign body macrophagic reaction. X-ray changes equate to endosteal scalloping/lysis, periosteal reaction and thickening of the cortex. Incidentally, all lengthened well and the bone regenerate looks good. The nail was explanted on an unknown date.
 
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Brand NamePRECICE STRYDE 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
tiara rae
101 enterprise dr, suite 100
aliso viejo, CA 92656
MDR Report Key11395262
MDR Text Key234751151
Report Number3006179046-2021-00156
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2021
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: 03/01/2021 Patient Sequence Number: 1
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