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

Model Number MS1-4590S

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation nor were xray films provided to confirm the alleged event.

Event Description

Received a report that indicated possible non distraction due to pin failure.Patient underwent a revision procedure on (b)(6) 2019 with no reported issues.

Manufacturer Narrative

Rod 1: a visual inspection of the returned rod revealed it was partially distracted.Functional testing could only be partially distracted and retracted using the erc, and unable to be distracted using the manual distractor.The rod was cut open and debris build up was found, which may have caused the 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.Rod 2: a visual inspection of the second rod revealed it was partially distracted with score marks on the distraction rod.The rod was able to lengthen by hand, which indicates a broken locking pin.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

Damaged returns: possible failure of internal distraction mechanism: suspected pin fracture.Significant amount of black debris in surrounding tissue.

• 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: 8496758
• MDR Text Key: 141468624
• Report Number: 3006179046-2019-00111
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS1-4590S
• Device Catalogue Number: PA0516
• 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
• Patient Age: 10 YR