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

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 xrays 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.

Event Description

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

Manufacturer Narrative

A visual inspection of the returned magec rods revealed to be partially distracted with score marks on the distraction rod.The distraction rod from both rods were able to be lengthened by hand, which indicates a broken locking pin.The pistoning action of the distraction rod due to a broken locking pin would allow for fluid ingress into the actuator.A device history record review revealed that the magec rods met all the required quality inspections and was 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: 8497401
• MDR Text Key: 141494129
• Report Number: 3006179046-2019-00113
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (y/n): N
• 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

• 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
• Device Lot Number: A140630-32
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization