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

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

This event is the same patient for mfr.Report # 3006179046-2018-00100.

Event Description

As per reporter post patient¿s initial procedure with the magec rod patient experienced a medical complication.Patient underwent a revision procedure without reported patient harm.

Manufacturer Narrative

This event is the same patient as 3006179046-2018-00100.

Event Description

Investigation related to complaint (b)(4) noted the parent reported that immediately after initial surgery, the patient experienced loss of bladder and bowel control secondary to hardware malplacement.This required catheter placement for each urination episode; bowel control was lost and required continuous use of diapers.Revision surgery to correct the malplacement resolved the loss of nerve control.

• 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, suite 100; aliso viejo CA 92656
• MDR Report Key: 8035344
• MDR Text Key: 126067340
• Report Number: 3006179046-2018-00104
• Device Sequence Number: 0
• Product Code: PGN
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/26/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11 YR