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

Model Number MS1-4570R

Device Problems Positioning Failure (1158); Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

Device yet to be obtained.

Event Description

It was reported that allegedly the patient's magec rod would not distract.The physician revised the magec rod with a new magec rod without incident.

Event Description

Dr sturm said rods stopped lengthening at 20mm.The rod was implanted on (b)(6) 2016.No patient injury reported.

Manufacturer Narrative

A visual inspection of the returned rod (b)(4) revealed it was partially distracted with score marks on the distraction rod.X-ray images of the internal components showed no damage.The rod was functionally tested and was unable to distract and retract with the manual distractor.However, the rod was able to distract and retract with an erc.The total stroke measurement, and distraction force testing met specification.A visual inspection of the second rod (b)(4) revealed it was partially distracted.The rod was functionally tested and could not be distracted or retracted using the manual distractor or erc.The rod was cut open and debris build up was found, which may have caused the reduced functionality of the rod.A review of the lot history records for the devices revealed that they met all of the required quality inspections and that the products were released within specifications.

• 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: 8031297
• MDR Text Key: 125911482
• Report Number: 3006179046-2018-00102
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

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: Health Professional
• Device Model Number: MS1-4570R
• Device Catalogue Number: PA0562
• Device Lot Number: A160502-09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR