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

Device Problem Material Discolored (1170)

Patient Problem Bacterial Infection (1735)

Event Type  malfunction  

Manufacturer Narrative

Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.Device evaluation provided by (b)(6): 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.Device returned to (b)(6).

Event Description

Information was received that 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.

• 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
• 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 Key: 11395635
• MDR Text Key: 234220468
• Report Number: 3006179046-2021-00153
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/01/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 65