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

Model Number MS1-5570S

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: device has not returned.

Event Description

It was reported that allegedly the patient's magec rods would not distract.Therefore, the physician performed a primary fusion on the patient with no complications.The patient had been implanted with the magec rods for almost (2) years.

Manufacturer Narrative

Rod 1, lot #a151116-24: a visual inspection of the returned rod revealed it was partially distracted with score marks on the distraction rod.Functional testing with the manual distractor and erc revealed that the rod was able to distract or retract.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.Rod 2, lot # a150717-12: a visual inspection of the returned rod revealed it was partially distracted with score marks on the distraction rod.Functional testing with the manual distractor and erc revealed that the rod was unable to distract or retract using the manual distractor and/or erc.The rod was cut open and debris build up was found, which may have caused the reduced functionality.A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.

Event Description

Rods originally implanted in (b)(6) 2017.Approximately 1-1.5cm of distraction was achieved and rods then stopped lengthening for 6 months.At that time, a primary fusion was performed on the patient.No complications other than apparent rod malfunction were 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, suite 100; aliso viejo CA 92656
• MDR Report Key: 8489143
• MDR Text Key: 141111780
• Report Number: 3006179046-2019-00109
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• PMA/PMN Number: K140613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MS1-5570S
• Device Catalogue Number: PA0563
• Device Lot Number: A150717-12, A151116-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR