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

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.

• 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: 11395262
• MDR Text Key: 234751151
• Report Number: 3006179046-2021-00156
• 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

• Date FDA Received: 03/01/2021
• 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
• Date Manufacturer Received: 02/05/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 68