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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unable to be determined at this time.

Event Description

Information was received that a revision procedure will be performed on (b)(6) 2020 as the nail has radiological changes at the male/female junction of the nail (lytic, cortical thickening, periosteal reaction).As per the surgeon, the patient is asymptomatic.

Event Description

See updated fields a2, a3, a4, b2, b6, b7, d6, h3, h6.

Manufacturer Narrative

Device evaluation provided by london implant retrieval center (lirc): patient showed evidence of cortical thickening pre-removal in bony regions aligned with the extendable junction of the nail.Corrosion scoring - the grading showed a contrast in the evidence of severe corrosion at the extendable junction of one nail compared with mild to no corrosion in the opposite nail.Surface damage - damage within the screw holes was predominately observed in holes 1-3 on the extending component of the nail.H3 other text: device returned to lirc.

• 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 Key: 10775524
• MDR Text Key: 214333183
• Report Number: 3006179046-2020-00426
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18 YR
• Patient Weight: 68