MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930)

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation nor were radiographs provided to confirm the alleged event.No root cause can be confirmed.

Event Description

Between january 2011 and october 2017, a 31 patient study in (b)(6) with a minimum of two-year follow up after implantation with the magec rod system in the treatment of eos, who were treated between december 2011 and october 2017.A (b)(6) female patient with a history of chromosomal abnormality underwent a dual rod procedure.However, 37 months post procedure, a broken actuator pin was observed for which the patient underwent a revision.Less than 1 month post revision surgery, the patient developed an infection (wound dehiscence) that required a washout, debridement and a convex rod removal.Information was received that a revision procedure was performed 37 months post procedure due to a locking pin failure.There was no patient injury reported.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 10858061
• MDR Text Key: 219365523
• Report Number: 3006179046-2020-00442
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 10/19/2020
• 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): Required Intervention
• Patient Age: 9 YR