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

Device Problems Material Discolored (1170); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); No Information (3190)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Root cause is unknown at this time.

Event Description

It was reported that a revision procedure was performed on (b)(6) 2020 due to lysis type imaging.X-ray changes equate to endosteal scalloping/lysis, periosteal reaction and thickening of the cortex.As per the surgeon, the patient was asymptomatic.

Event Description

See updated fields a2, a4, b1, b6, b7, d6, d8, h3, h6.

Manufacturer Narrative

Device labeling: metallic implants can loosen, fracture, corrode, migrate or cause pain.Device evaluation provided by lirc: 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.Plain radiographs captured of patient post-implantation showed evidence of cortical thickening pre-removal in bony regions aligned with the extendable junction of the nails.Surface damage: damage within the screw holes was predominately observed in holes 1-3.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: 10766050
• MDR Text Key: 214122055
• Report Number: 3006179046-2020-00422
• 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

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 14 YR
• Patient Weight: 44