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

Model Number MC2-5090R

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Skin Discoloration (2074)

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Even though no product has been returned, fsca investigation was performed and variation in the torque applied to the threaded cap during the assembly process was identified as the root cause of the failure.Per the manufacturing instructions, the threaded cap must be tightened to 40 in-lbs.Although all operators followed the assembly procedure, and the torque wrench indicated 40 in-lbs was applied, the manner of using the torque wrench resulted in variances in applied torque.The manner in which the operator handles the torque wrench may impact the actual torque applied to the end cap, thereby creating a false positive that the specified torque has been applied.If the specified torque is not applied, the effectiveness of the cap tightening process may be compromised.

Event Description

Information was received that x-rays noted the end cap had become displaced.Additionally, it was reported that there was blackening of the tissue.There is no revision procedure planned at this time.No patient injury was 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 dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise dr, suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 11439761
• MDR Text Key: 239103705
• Report Number: 3006179046-2021-00168
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00887517834034
• UDI-Public: 887517834034
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2-5090R
• Device Lot Number: 9091318AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• 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
• Removal/Correction Number: Z-1898-2020
• Patient Sequence Number: 1
• Patient Age: 13 YR