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

Model Number MS1-4590S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  Injury  

Event Description

It was alleged that the patient's magec rods would not distract.The physician revised the rods with new magec rods without incident.

Manufacturer Narrative

Rod 1 lot # 150128-10: a visual inspection of the returned rod revealed it was partially distracted.Functional testing revealed that the rod could distract and retract with the manual distractor.It was determined the rod was functional.Rod 2 lot # 150428-13: a visual inspection of the returned rod revealed it was partially distracted.Functional testing revealed the rod could not be distracted or retracted using the manual distractor.The rod was able to be distracted and retracted with the erc.The rod was observed to have score marks and debris build up, which may have caused the reduced functionality of the rod.

• 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
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise, suite 100; aliso viejo CA 92656
• Manufacturer Contact: carol bleakley ; 101 enterprise, suite 100; aliso viejo, CA 92656
• MDR Report Key: 7562944
• MDR Text Key: 109892588
• Report Number: 3006179046-2018-00043
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: MS1-4590S
• Device Catalogue Number: PA0516
• Device Lot Number: A141118-01, A141210-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 09/05/2018
• 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; Required Intervention
• Patient Age: 9 YR