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

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Even though no product has been returned due to the device remaining implanted, an 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-ray images revealed that the end cap had fallen off.No revision procedure has been performed at this time.There was no patient injury 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: 11092299
• MDR Text Key: 224388225
• Report Number: 3006179046-2020-00525
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• 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 Outcome(s): Hospitalization; Other
• Patient Age: 5 YR
• Patient Weight: 19